This phase II trial studies whether [18F]FTT can be used with positron emission tomography (PET)/computed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET/CT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, [18F]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient’s body. [18F]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET/CT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using [18F]FTT with PET/CT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07673341.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Approved
Contact: Angela M. Castellanos Rodriguez
Phone: 206-606-6777
PRIMARY OBJECTIVE:
I. Determine the relationship between baseline fluorine F 18 fluorthanatrace ([18F]FTT) uptake, defined as the maximum standard uptake value (SUVmax) in the most avid lesion on [18F]FTT PET, and overall response to first line gemcitabine and cisplatin (GC) and durvalumab (GCD).
SECONDARY OBJECTIVES:
I. Determine the relationship between the mean SUV (SUVmean) of the most [18F]FTT-avid lesion on baseline [18F]FTT PET, and overall response rate to GCD.
II. Determine whether the change in SUVmax and SUVmean of the most [18F]FTT-avid lesion from baseline to after the 3rd cycle of GCD is associated with response Response Evaluation Criteria in Solid Tumors (RECIST)-defined response at the 3rd cycle of GCD.
EXPLORATORY OBJECTIVES:
I. Explore relationship of total tumor volume (TTV) [18F]FTT SUVmean at baseline and change in TTV SUVmean on [18F]FTT PET SUVmean TTV after three cycles of GCD with overall treatment response.
II. Explore differences in SUVmax and SUVmean of the most avid lesion on [18F]FTT PET and in TTV SUVmean in the presence or absence of biologically relevant mutations, including BRCA1/2 and IDH1 mutations, obtained by standard-of-care clinical genetic testing.
OUTLINE:
Patients receive [18F]FTT intravenously (IV) and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or magnetic resonance imaging (MRI) throughout the study.
After completion of study intervention, patients are followed up at week 24 and then up to 6 months after completing GCD treatment.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorAngela M. Castellanos Rodriguez
