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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02455 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0442 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well positron emission tomography/magnetic resonance (PET/MR) versus contrast enhanced computerized tomography (CECT) scans work in locating ovarian cancer tumors in patients with known or suspected ovarian cancer. PET, MR, and CECT scans use different methods to create images of areas inside the body. This trial is being done to see if PET/MR scans may help doctors locate ovarian cancer tumors, predict how well these tumors may be removed during surgery, and predict how patients respond to platinum-based chemotherapies compared to standard of care CECT scans.
PRIMARY OBJECTIVE:
I. To compare PET/MR and contrast enhanced computed tomography (CT) to determine the accuracy in patients with advanced-stage serous ovarian cancer or highly suspected ovarian cancer using diagnostic laparoscopy as the gold standard with respect to lesion detection.
SECONDARY OBJECTIVES (EXPLORATORY):
I. Correlating imaging findings such as enhancement pattern, apparent diffusion coefficient (ADC) values, standardized uptake value (SUV) values, and advanced image analytics such as texture with pathology and genomic analysis for those lesions evaluated as a discovery arm.
II. Assess whether MR (multiparametric and functional) and PET findings predict response to platinum based chemotherapy.
III. To compare PET/MR and contrast enhanced CT to predict tumor negative (R0) resection using surgery as the gold standard.
OUTLINE:
Patients undergo standard of care CECT scan and PET-MRI scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction. Patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional PET-MRI and standard of care CECT scans after completion of chemotherapy and before cytoreduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CECT, PET-MRI) | Experimental | Patients undergo standard of care CECT scan and PET-MRI scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction. Patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional PET-MRI and standard of care CECT scans after completion of chemotherapy and before cytoreduction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Enhanced CT | Radiation | Undergo standard CECT |
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| Measure | Description | Time Frame |
|---|---|---|
| Lesion detection accuracy | Lesion detection accuracy will be summarized using frequencies and percentages by modality. McNemar's test will be used to compare accuracies between positron emission tomography (PET)/magnetic resonance (MR) and contrast enhanced computerized tomography (CECT). Other diagnostic metrics (sensitivity, specificity, positive predictive value, and negative predictive value) will be estimated along with 95% confidence intervals. Logistic regression model will be used to assess effect of patient and tumor characteristics on diagnostic accuracy. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy by location | Will be analyzed using linear regression or generalized linear regression models where applicable. | Up to 3 years |
| Response status | Will be analyzed using linear regression or generalized linear regression models where applicable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priya R Bhosale | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Magnetic Resonance Imaging | Procedure | Undergo PET/MRI scan |
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| Positron Emission Tomography | Procedure | Undergo PET/MRI scan |
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| Up to 3 years |
| Imaging and genomic data analysis | Correlation between imaging and genomic data will be analyzed using linear regression or generalized linear regression models where applicable. | Up to 3 years |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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