This pilot phase I trial studies fluorine 18 (F 18) fluorthanatrace biodistribution (to see how it is taken up in the body), metabolism and excretion analysis in patients with ovarian, fallopian tube or primary peritoneal cancer. Fluorine F 18 fluorthanatrace is a radioactive substances that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET) and computed tomography (CT). Poly adenosine diphosphate ribose polymerase (PARP-1) is an enzyme that helps regulate cell process, such as cell growth, cell death and detect deoxyribonucleic acid (DNA) damage. Fluorine F 18 fluorthanatrace may be used to detect PARP-1 activity in tumors. Imaging PARP-1 activity in patients with ovarian, fallopian tube or primary peritoneal cancer may help doctors understand its function and determine the best way to use imaging to help study new treatments that target the PARP-1 enzyme.
Additional locations may be listed on ClinicalTrials.gov for NCT02637934.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Temporarily closed to accrual
Contact: Fiona Simpkins
Phone: 215-662-7336
PRIMARY OBJECTIVES:
I. Evaluate poly adenosine diphosphate ribose polymerase (PARP-1) activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of ([18F] FluorThanatrace [fluorine F 18 fluorthanatrace]).
SECONDARY OBJECTIVES:
I. Evaluate the safety of [18F] FluorThanatrace.
II. Correlate [18F] FluorThanatrace uptake measures with breast cancer, early onset (BRCA) mutation status.
III. Correlate [18F] FluorThanatrace uptake measures with PARP-1 activity in tumor tissue samples in patients who undergo biopsies.
IV. Determine biodistribution of the radioactive investigational drug ([18F]FluorThanatrace) in patients and calculate human dosimetry.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I (BIODISTRIBUTION) (CLOSED TO ACCRUAL): Patients receive fluorine F 18 fluorthanatrace intravenously (IV) and undergo positron emission tomography (PET)/ computed tomography (CT) scan (top of the head to mid-thigh) over 4 hours. Patients undergo blood sample collection and may optionally undergo tumor biopsy on study.
COHORT II (DYNAMIC): Patients fluorine F 18 fluorthanatrace IV and undergo PET/CT scan (over the abdomen/pelvis) over 60 minutes. Patients undergo blood sample collection and may optionally undergo tumor biopsy on study.
After completion of study, patients are followed up for 24 hours.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorFiona Simpkins