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Hypothesis:
The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.
This study is a prospective single center study.
Hypothesis:
We would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility. This study allows us to assess the feasibility of such a large-scale study, but also to evaluate COMBI TEP performance. From these estimates, we can then consider a comparative study to evaluate the performance of COMBI PET.
This study is a prospective single center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMBI TEP : PET / enhanced CT scan | Experimental | COMBI TEP : PET / enhanced CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMBI TEP : PET / enhanced CT scan | Device | diagnostic imaging exam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions | The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level | The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study |
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Inclusion Criteria:
Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:
Digestive cancers
Colorectal cancer
Esophageal cancer: initial staging.
Pancreatic cancer
Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
Lung cancer
Head and neck cancer
Lymphoma
Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
Ovarian cancer recurrence
Age ≥ 18 years.
Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
Woman of childbearing age with negative pregnancy test and / or contraception.
Patient with informed consent signed.
Patient affiliated to social security schemes.
Exclusion Criteria:
Iodine known allergy.
Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
Known renal failure (creatinine clearance <60ml/min).
Indications against Xenetix ®:
Pregnant or lactating women.
Unable to undergo medical follow up for geographical, social or psychological reasons,
Private of freedom patient and adult under a legal guardianship or unable to consent.
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| Name | Affiliation | Role |
|---|---|---|
| CAZEAU Anne Laure, MD | Institut Bergonié | Study Chair |
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| Label | URL |
|---|---|
| Site internet du promoteur, l'Institut Bergonié | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | COMBI TEP : PET / Enhanced CT Scan | COMBI TEP : PET / enhanced CT scan : diagnostic imaging exam First, realisation of CT scan without injection followed by a PET scan (TEPSCAN) on the same Phillips GEMINI TF PET/CT camera. A few minutes after the TEPSCAN, injection CT is performed (XenetiX, iodinated contrast agent 350 mg l/mL). The COMBI TEP exam includes the TEP and the 2 series of scans (not injected low dose and injected full dose). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | COMBI TEP : PET / Enhanced CT Scan | COMBI TEP : PET / enhanced CT scan COMBI TEP : PET / enhanced CT scan: diagnostic imaging exam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions | The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study | Eligible patients with PET-CT scanner performed AND interpretation of 2 pairs of observors available. | Posted | Number | 95% Confidence Interval | Weighted kappa concordance coefficient | 1 year |
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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 | COMBI TEP : PET / Enhanced CT Scan | COMBI TEP : PET / enhanced CT scan COMBI TEP : PET / enhanced CT scan: diagnostic imaging exam |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne-Laure Cazeaux, Nuclear physician | Institut Bergonié, Medical Imaging Department | 05.56.33.78.60 | A.cazeaux@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 year |
| Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions | For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study | 1 year |
| Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level | The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study | 1 year |
| Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions | For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study. | 1 year |
| Intra-observer Reproducibility of Injected CT Scanat a Patient Level | The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study. | 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Missing data for 7 data | Mean | Standard Deviation | kilogram |
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| height | Missing data for 37 patients | Mean | Standard Deviation | centimetre |
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| Tumor localisation | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | COMBI TEP : PET / Enhanced CT Scan | COMBI TEP : PET / enhanced CT scan COMBI TEP : PET / enhanced CT scan: diagnostic imaging exam |
|
|
| Secondary | Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level | The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study | Reproducibility was not calculated for 1 patient because 9 area from thorax region were not assessed by the pair of observer B2. | Posted | Number | 95% Confidence Interval | weighted Kappa coefficient | 1 year |
|
|
|
| Secondary | Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions | For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study | Interpretation by nuclear physician alone was not performed for 1 patient | Posted | Number | 95% Confidence Interval | Weighted kappa concordance coefficient | 1 year |
|
|
|
| Secondary | Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level | The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study | Interpretation by nuclear physician alone was not performed for 1 patient. Interpretation by the pair of observor B2 was incomplete for 1 patient because 9 area from thorax region were not assessed. | Posted | Number | 95% Confidence Interval | Weighted kappa concordance coefficient | 1 year |
|
|
|
| Secondary | Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions | For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study. | Posted | Number | 95% Confidence Interval | Weighted Kappa concordance coefficient | 1 year |
|
|
|
| Secondary | Intra-observer Reproducibility of Injected CT Scanat a Patient Level | The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study. | Posted | Number | 95% Confidence Interval | Weighted Kappa concordance coefficient | 1 year |
|
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| 0 |
| 109 |
| 0 |
| 109 |
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| Pelvis region |
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| Bone region |
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| Nervous system region |
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| Title | Measurements |
|---|---|
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| Bone region |
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| Nervous system region |
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