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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| Ligue contre le cancer, France | OTHER |
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This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.
This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional imaging | Experimental | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Imaging previous the second course | Device | Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Pre-therapeutic |
| Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Pre-therapeutic |
| Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Pre-therapeutic |
| Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
| Measure | Description | Time Frame |
|---|---|---|
| Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure CAZEAU, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Gironde | 33076 | France |
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| Label | URL |
|---|---|
| Registre des essais cliniques de l'Institut National du Cancer | View source |
| Site internet du promoteur, l'Institut Bergonié | View source |
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The first steering committee (which met on 30th June, 2015) decided that one patient was not assessable for primary endpoint and had to be replaced. This patient deceased after the first line chemotherapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Imaging | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Imaging | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
|
All adverse events are recorded from the first visit (J0 inclusion) until 4 weeks after the third PET/MRI examination. Beyond this period, only SAE likely to be related to the research or the medical device or to the procedure of implementation of the medical device are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Imaging | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Laure Cazeau, Coordinating Investigator | Institute Bergonie | 0556337860 | A.Cazeau@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Functional Imaging previous the surgery | Device | Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
|
| Pre-therapeutic |
| Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Pretherapeutic |
| Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Pretherapeutic |
| Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist. | After one cycle of chemotherapy, 3 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After one cycle of chemotherapy, 3 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After one cycle of chemoterapy, 3 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After one cycle of chemotherapy, 3 weeks |
| Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After one cycle of chemotherapy, 3 weeks |
| Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After one cycle of chemotherapy, 3 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After four cycles of chemotherapy, 12 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After four cycles of chemotherapy, 12 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After four cycles of chemoterapy, 12 weeks |
| Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After four cycles of chemotherapy, 12 weeks |
| Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After four cycles of chemotherapy, 12 weeks |
| Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | After four cycles of chemotherapy, 12 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Pre-therapeutic |
| Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Pre-therapeutic |
| Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Pre-therapeutic |
| Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Pre-therapeutic |
| Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Pretherapeutic |
| Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Pretherapeutic |
| Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After one cycle of chemoterapy, 3 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After once cycle of chemoterapy, 3 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After one cycle of chemoterapy, 3 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After once cycle of chemotherapy, 3 weeks |
| Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After one cycle of chemotherapy, 3 weeks |
| Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After one cycle of chemotherapy, 3 weeks |
| Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After four cycles of chemoterapy, 12 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After four cycles of chemoterapy, 12 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After four cycle of chemoterapy, 12 weeks |
| Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After four cycles of chemotherapy, 12 weeks |
| Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After four cycles of chemotherapy, 12 weeks |
| Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | After four cycles of chemotherapy, 12 weeks |
| After one cycle of chemotherapy, 3 weeks |
| Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. | After four cycles of chemotherapy, 12 weeks |
| Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. | After one and four cycle(s) of chemotherapy (after 3 and 12 weeks) |
| Complete Surgery Resection | Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery |
| Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After one cycle of chemotherapy, 3 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After four cycles of chemotherapy, 12 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After four cycles of chemotherapy, 12 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After one cycle of chemotherapy, 3 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After one cycle of chemotherapy, 3 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After four cycles of chemotherapy, 12 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After one cycle of chemotherapy, 3 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After four cycles of chemotherapy, 12 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After one cycle of chemotherapy, 3 weeks |
| Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After four cycles of chemotherapy, 12 weeks |
| Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After one cycle of chemotherapy, 3 weeks |
| Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | After four cycles of chemotherapy, 12 weeks |
| Peritoneal Extent Assessed by Fagotti Score Using MRI Data | The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score. | Pre-therapeutic |
| Peritoneal Extent Assessed by Fagotti Score Using MRI Data | TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score. | Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery |
| Overall Survival | 10 months |
| Progression-free Survival as Per RECIST v1.1 | 9, 13, 14 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Proven epithelial carcinoma of gynaecological origin | Count of Participants | Participants |
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| Location of the tumour | Count of Participants | Participants |
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| Histological type | Count of Participants | Participants |
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| Stage of the tumour | The stage of tumour is graded from I-a to IV-c. The higher the stage number/letter is, the further the cancer has spread. | Count of Participants | Participants |
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| Total Fagotti Score | The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of all subscale values corresponds to Fagotti score. | Count of Participants | Participants |
|
| Performance status ECOG | Performance status ECOG questionnaire is a tool for measuring the degree of autonomy of a person through his or her ability to carry out certain tasks of daily life. The score ranges from 0 (able to carry out the same activity as before the illness without any restrictions) and stage 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) to stade 4 (unable to take care of himself, bedridden or in a chair all the time). | Count of Participants | Participants |
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| Weight | Median | Full Range | Kg |
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| Height | Median | Full Range | cm |
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| Number of measurable initial lesions | Count of Participants | Participants |
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| Number of non-target lesions | Count of Participants | Participants |
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| Sum of the diameters | Median | Full Range | diameters |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location at baseline : only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pretherapeutic |
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| Primary | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pretherapeutic |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemoterapy, 3 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after one cycle of chemotherapy : only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after once cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemoterapy, 12 weeks |
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| Primary | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions). | Posted | Number | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. | For patients with lesions by location after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions). | Posted | Number | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location at baseline: only one patient with lesions in viscera locations | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location at baseline: only one patients with lesions in viscera locations and nine patients with sus-mesocolic lesion | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location at baseline : only nine patients with sub-mesocolic lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location at baseline : only nine patients with sub-mesocolic lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pre-therapeutic |
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| Primary | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pretherapeutic |
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| Primary | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | Pretherapeutic |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemoterapy, 3 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After once cycle of chemoterapy, 3 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemoterapy, 3 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Eligible and evaluable population | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After once cycle of chemotherapy, 3 weeks |
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| Primary | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location after one cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location after one cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After one cycle of chemotherapy, 3 weeks |
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| Primary | Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location after one cycle of chemotherapy: only one patients had sus-mesocolic lesions, nine sub-mesocolic lesion, one ADP lesions and no patient had visceral lesion. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemoterapy, 12 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | Eligible and evaluable population. Only one patient had sus-mesocolic lesions, one patient ADP lesions, nine patients sub-mesocolic lesions and no patient had supra-diaphragmatic or viscera lesions | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemoterapy, 12 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in the location of supra-diaphragmatic and viscera | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycle of chemoterapy, 12 weeks |
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| Primary | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions by location after four cycles of chemotherapy: No patients with supra-diaphragmatic lesions or viscera lesions. | Posted | Number | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Primary | Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. | For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions. | Posted | Geometric Mean | 95% Confidence Interval | proportion of agreement | After four cycles of chemotherapy, 12 weeks |
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| Secondary | Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. | Eligible and evaluable population | Posted | Number | 95% Confidence Interval | Spearman's correlation coefficient | After one cycle of chemotherapy, 3 weeks |
|
|
|
| Secondary | Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. | Eligible and evaluable population | Posted | Number | 95% Confidence Interval | Spearman's correlation coefficient | After four cycles of chemotherapy, 12 weeks |
|
|
|
| Secondary | Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. | Posted | Number | 95% Confidence Interval | Spearman's correlation coefficient | After one and four cycle(s) of chemotherapy (after 3 and 12 weeks) |
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|
|
| Secondary | Complete Surgery Resection | Posted | Count of Participants | Participants | Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery |
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Posted | Median | Standard Deviation | change in relative variance | After one cycle of chemotherapy, 3 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of SUVmax by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After four cycles of chemotherapy, 12 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Posted | Median | Standard Deviation | change in relative variance | After four cycles of chemotherapy, 12 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of MTV by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After one cycle of chemotherapy, 3 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of SUVN by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After one cycle of chemotherapy, 3 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of SUVN by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After four cycles of chemotherapy, 12 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of TLG by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After one cycle of chemotherapy, 3 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of TLG by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After four cycles of chemotherapy, 12 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of TLG by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After one cycle of chemotherapy, 3 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of TLG by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After four cycles of chemotherapy, 12 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of ADC by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After one cycle of chemotherapy, 3 weeks |
|
|
|
|
| Secondary | Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1 | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). | Relative variations of SUVmax by response : 8 partial response and 2 stable disease | Posted | Median | Standard Deviation | change in relative variance | After four cycles of chemotherapy, 12 weeks |
|
|
|
|
| Secondary | Peritoneal Extent Assessed by Fagotti Score Using MRI Data | The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score. | Posted | Count of Participants | Participants | Pre-therapeutic |
|
|
|
| Secondary | Peritoneal Extent Assessed by Fagotti Score Using MRI Data | TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score. | Posted | Count of Participants | Participants | Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery |
|
|
|
| Secondary | Overall Survival | Posted | Number | 95% Confidence Interval | percentage of patients | 10 months |
|
|
|
| Secondary | Progression-free Survival as Per RECIST v1.1 | Posted | Number | 95% Confidence Interval | percentage of patients | 9, 13, 14 months |
|
|
|
| 1 |
| 11 |
| 3 |
| 11 |
| 11 |
| 11 |
|
| Colonic obstruction | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment | Gastrointestinal disorders |
|
| Sepsis | Infections and infestations | CTCAE v5.0 | Systematic Assessment | Infections and infestations |
|
|
| Sinus tachycardia | Cardiac disorders | CTCAE v5.0 | Non-systematic Assessment | Cardiac disorders |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Ascites | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Bloating | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Fatigue | General disorders | CTCAE v5.0 | Non-systematic Assessment | General disorders and administration site conditions |
|
| Fever | General disorders | CTCAE v5.0 | Non-systematic Assessment | General disorders and administration site conditions |
|
| Allergic reaction | Immune system disorders | CTCAE v5.0 | Non-systematic Assessment | Immune system disorders |
|
| Bronchial infection | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment | Infections and infestations |
|
| Enterocolitis infectious | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment | Infections and infestations |
|
| Peritoneal infection | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment | Infections and infestations |
|
| Urinary tract infection | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment | Infections and infestations |
|
| Creatinine increased | Investigations | CTCAE v5.0 | Non-systematic Assessment | Investigations |
|
| Neutrophil count decreased | Investigations | CTCAE v5.0 | Non-systematic Assessment | Investigations |
|
| Platelet count decreased | Investigations | CTCAE v5.0 | Non-systematic Assessment | Investigations |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment | Musculoskeletal and connective tissue disorders |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment | Nervous system disorders |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment | Renal and urinary disorders |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment | Renal and urinary disorders |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment | Reproductive system and breast disorders |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment | Reproductive system and breast disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment | Skin and subcutaneous tissue disorders |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment | Skin and subcutaneous tissue disorders |
|
| Hypertension | Vascular disorders | CTCAE v5.0 | Non-systematic Assessment | Vascular disorders |
|
| Thromboembolic event | Vascular disorders | CTCAE v5.0 | Non-systematic Assessment | Vascular disorders |
|
Not provided
Not provided
Not provided
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Title | Measurements |
|---|---|
|
| Pelvis |
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| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
| Title | Measurements |
|---|---|
|
| Pelvis |
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| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
| Title | Measurements |
|---|---|
|
| Pelvis |
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
|
| Sub-mesocolic |
|
|
| Pelvis |
|
|
| Viscera |
|
|
| ADP |
|
|
| Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN |
|
| Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL |
|
| Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG |
|
| Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN |
|
| Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL |
|
| Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG |
|
|
|
|
|
|
|
|
|
|
|
| 12 |
|
| Missing |
|
| 6 |
|
| 8 |
|
| 10 |
|
| Title | Measurements |
|---|---|
|