This pilot, early phase I trial studies how well 18F-FluorThanatrace positron emission tomography/computed tomography (PET/CT) scans work before and after treatment in identifying PARP-1 activity in patients with pancreatic adenocarcinoma. PARP-1 is a type of enzyme (protein) that helps with different functions of cells, including growth, cell death, recognizing deoxyribonucleic acid (DNA) damage, and DNA repair. 18F-FluorThanatrace is a type of drug called a radioactive tracer that is injected into the body to trace PARP-1 activity in a tumor during an imaging study. 18F-FluorThanatrace PET/CT scans may help researchers understand how PARP-1 functions as well as determine the best way to use imaging to study treatments that target PARP-1.
Additional locations may be listed on ClinicalTrials.gov for NCT03492164.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES
I. To evaluate feasibility of measuring PARP-1 expression in pancreatic cancer suspected or confirmed to have an HRD, using fluorine F 18 fluorthanatrace ([18F] FluorThanatrace [(18F)FTT]).
II. To evaluate PARP-1 expression in pancreatic cancer using measures of uptake of [18F]FTT.
SECONDARY OBJECTIVES
I. To evaluate the safety of [18F]FTT.
II. To correlate [18F]FTT uptake measures with PARP-1 immunohistochemistry (IHC) expression in the tissue specimen.
III. To correlate [18F]FTT uptake measures with PARP-1 [125I]KX1 autoradiography expression in the tissue specimen.
IV. To determine pre-/post-treatment changes in [18F]FTT uptake.
V. To determine whether pre-/post-treatment changes in [18F]FTT uptake predict clinical response as measured by progression-free survival (PFS).
OUTLINE:
Patients receive fluorine F 18 fluorthanatrace ([18F]FTT) intravenously (IV), then undergo a positron emission tomography (PET)/computed tomography (CT) scan over 60 minutes prior to starting PARP inhibition therapy. Approximately 60 minutes after post-injection, patients may undergo an additional scan over 15-25 minutes per physician discretion. Patients may also undergo a second [18F]FTT PET/CT scan approximately 3 weeks after the start of PARP inhibition therapy per physician discretion.
After completion of study treatment, patients are followed up for 24 hours.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorAustin Ryan Pantel
