This early phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography/magnetic resonance imaging (PET/MR) imaging works in measuring poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) in patients with cancer. PARP is a deoxyribonucleic acid (DNA) repair enzyme that enables normal cell survival as well as certain cancers. Diagnostic procedures, such as fluorine F 18 fluorthanatrace PET/MRI may help accurately measure PARP activity in patients with cancer. Measuring tumoral PARP activity levels before and after treatment may help determine which patients are good candidates for PARP inhibitor therapy and confirm that adequate doses of PARP inhibitors are administered to patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02469129.
PRIMARY OBJECTIVES:
I. Demonstrate that fluorine F 18 fluorthanatrace [18F]FTT imaging is feasible in cancer patients.
II. Demonstrate that [18F]FTT uptake correlates with PARP expression and activity in tumor tissue samples.
III. Demonstrate effects of systemic therapy regimens on [18F]FTT uptake, and [18F] fludeoxyglucose (FDG) uptake.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM 1 (DOSIMETRY): Patients receive [18F]FTT intravenously (IV) followed by whole-body PET imaging at 0 and 120 minutes, 30 and 150 minutes, 60 and 180 minutes, or 90 and 210 minutes after tracer injection. (DOSIMETRY STUDY HAS BEEN COMPLETED)
ARM 2 (KINETICS): Patients receive [18F]FTT IV followed by whole-body PET imaging over 60 minutes starting at the time of injection. Patients then undergo 2 additional PET/MRI scans as the end of the 60-min scan and at 120 minutes post [18F]FTT injection. Patients undergoing chemotherapy undergo PET scans before starting chemotherapy and 2-4 weeks after completion of the second course of chemotherapy. Patients undergoing PARP inhibitor therapy, undergo PET scans before starting PARP inhibitor therapy, and at approximately 3 months from the start of therapy or earlier at disease progression.
After completion of study, patients are followed up at day 2.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorFarrokh Dehdashti
