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NCT03965481 Clinical Trial

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

Ovarian Carcinoma Clinical Trial

Official title:
Comparing Accuracy of PET/MR vs. CECT in Assessment of Peritoneal Disease for Resectability in Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03965481
Other study ID # 2017-0442
Secondary ID NCI-2019-0245520
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 12, 2018
Est. completion date April 30, 2025

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 21
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
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: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Dynamic Enhanced CT
Undergo standard CECT
Procedure:
• Magnetic Resonance Imaging
Undergo PET/MRI scan
• Positron Emission Tomography
Undergo PET/MRI scan

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary Diagnostic accuracy by location Will be analyzed using linear regression or generalized linear regression models where applicable. Up to 3 years
Secondary Response status Will be analyzed using linear regression or generalized linear regression models where applicable. Up to 3 years
Secondary 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
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