This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body (metastasis). 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03857087.
PRIMARY OBJECTIVES:
I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.
II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.
SECONDARY OBJECTIVE:
I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.
EXPLORATORY OBJECTIVES:
I. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.
II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging, and MRI-derived tumor perfusion.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After about 60 minutes, patients undergo PET/magnetic resonance imaging (MRI) for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.
After completion of study, patients are followed up at 1-2 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorMichael Ohliger
