PET/MR Versus CECT Scans in Imaging Patients with Ovarian Cancer or Highly Suspected Ovarian Cancer

Not Applicable

Active, not recruiting

Interventions: Radiation: Dynamic Enhanced CT
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Diagnostic (CECT, PET-MRI)	Magnetic Resonance Imaging	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.
Diagnostic (CECT, PET-MRI)	Dynamic Enhanced CT	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.
Diagnostic (CECT, PET-MRI)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Response status	Up to 3 years	Will be analyzed using linear regression or generalized linear regression models where applicable.
Diagnostic accuracy by location	Up to 3 years	Will be analyzed using linear regression or generalized linear regression models where applicable.