Malignant Ovarian Neoplasm, Ovarian Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONDynamic Enhanced CT
Undergo standard CECT
PROCEDUREMagnetic Resonance Imaging
Undergo PET/MRI scan
PROCEDUREPositron Emission Tomography
Undergo PET/MRI scan
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ovarian cancer or highly suspected ovarian cancer who are eligible to undergo laparoscopic evaluation for resectability will be enrolled in the trial. * Patients who have estimated glomerular filtration rate (eGFR) \> 30.
Exclusion criteria
* Patients allergic to gadolinium. * Patients who have eGRF \< 30. * Patients with cardiac pacers. * Pediatric patients. * Greater than 400 pounds in weight. * Blood glucose (\> 200 mg/dl). * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion detection accuracy | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy by location | Up to 3 years | Will be analyzed using linear regression or generalized linear regression models where applicable. |
| Response status | Up to 3 years | Will be analyzed using linear regression or generalized linear regression models where applicable. |
| Imaging and genomic data analysis | Up to 3 years | Correlation between imaging and genomic data will be analyzed using linear regression or generalized linear regression models where applicable. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPriya R Bhosale
M.D. Anderson Cancer Center
Outcome results
None listed