This phase I trial evaluates a radioactive tracer, a type of imaging drug that is injected into the body to help see PARP-1 activity using an imaging procedure called positron emission tomography (PET)/computed tomography (CT) in patients with pheochromocytoma and paraganglioma (tumor that forms in the center of the adrenal gland [gland located above the kidney]). Poly (ADP-ribose) polymerase-1 is also called PARP-1, is a protein in the body that helps with many cell processes. PARP-1 has been studied for a number of years in cancer treatment as PARP inhibitor drugs. 18fluorine-fluorthanatrace ([18F]-FTT) is a specialized radioactive imaging drug used to create pictures or images of areas where doctors think tumor is from, pheochromocytoma or paraganglioma, that might have PARP-1 activity. This study may help researchers learn whether test 18F-FTT can show PARP-1 activity in patients with pheochromocytoma and paraganglioma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05636540.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Heather Wachtel
Phone: 215-662-2341
PRIMARY OBJECTIVE:
I. To evaluate PARP-1 activity in pheochromocytoma and paraganglioma using measures of uptake of [18F]fluorthanatrace.
SECONDARY OBJECTIVES:
I. To correlate [18F]fluorthanatrace uptake measures with PARP-1 activity in the biopsy and/or surgical specimen 1 [125I]KX1 autoradiography activity.
II. To correlate [18F]fluorthanatrace uptake measures with known hereditary predisposition genes.
OUTLINE:
Patients receive [18F]-FFT intravenously (IV) and undergo PET/CT over 60 minutes prior to start of PARP inhibitor therapy, chemotherapy and/or ADT. Patients may also receive additional [18F]-FFT IV and undergo PET/CT 1-21 days after start of PARP inhibitor therapy, chemotherapy and/or ADT. Patients may also undergo tumor tissue sample collection on study.
After completion of study treatment, patients are followed up 24 hours following [18F]-FTT injection.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorHeather Wachtel
