This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in imaging patients with ovarian, fallopian tube, or primary peritoneal cancer that is primary or has come back (recurrent). Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may help detect the activity of a certain enzyme in the body that may be related to cancer growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03604315.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Lilie L. Lin
Phone: 713-563-2300
PRIMARY OBJECTIVES:
I. Evaluate fluorine F 18 fluorthanatrace ([18F]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly [ADP-ribose] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor.
SECONDARY OBJECTIVES:
I. Evaluate the safety of [18F]Fluorthanatrace.
II. Correlate [18F]Fluorthanatrace uptake measures with BRCA mutation status.
III. Correlate [18F]Fluorthanatrace uptake measures with PARP-1 activity in tumor tissue samples in patients who undergo biopsies.
IV. Evaluate change in [18F]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation.
V. To confirm the variability of imaging findings from repeated [18F]fluorthanatrace (FTT) PET/CT over 1 week before treatment initiation.
OUTLINE:
Patients receive fluorodeoxyglucose (FDG) intravenously (IV) and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo fluorine F 18 fluorthanatrace ([18F]FTT) PET/CT over 1 hour.
After completion of study treatment, patients are followed up at 24 hours.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLilie L. Lin
