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
Verified date | April 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
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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