This clinical trial studies how well positron emission tomography (PET) with fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) works in detecting tumors in patients with advanced epithelial ovarian, fallopian tube, or peritoneal cancer. PET imaging using 18F-FSPG may identify tumors when they are smaller and more responsive to various treatment(s).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02872519.
PRIMARY OBJECTIVES:
I. To evaluate the relationship between fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography/computed tomography (PET/CT) and pathology in patients with suspected ovarian cancer scheduled for cytoreductive surgery.
II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic computed tomography (CT) imaging and surgical findings in patients with suspected ovarian cancer scheduled for surgical resection.
III. To compare the uptake of 18F-FSPG PET/CT before and after treatment in patients who undergo neoadjuvant platinum-based chemotherapy followed by interval cytoreductive surgery.
OUTLINE:
Patients receive fluorine F 18 L-glutamate derivative BAY94-9392 intravenously (IV). Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B).
After completion of study, patients are followed up periodically for at least 6 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorMarta Ann Crispens