This phase II trial studies how well fluorothymidine F-18 positron emission tomography (PET)/computed tomography (CT) works in predicting outcome in participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Fluorothymidine F-18 PET/CT may help in evaluating the type of cancer and predicting how well the cancer responds to therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03318497.
PRIMARY OBJECTIVE:
I. To assess if percentage change in fluorothymidine F-18 (18FFLT) PET/CT quantitative parameters (standardized uptake value [SUV] maximum [max], or SUV peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict overall survival at 1 and 2 years in patients with resectable, borderline resectable or locally advanced pancreatic adenocarcinoma.
SECONDARY OBJECTIVE:
II. To assess if percentage change in 18FFLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict progression free survival at 6 months and 1 year in patients with resectable, borderline resectable or locally advanced pancreatic adenocarcinoma.
OUTLINE:
Participants receive fluorothymidine F-18 intravenously (IV) over 1-2 minutes and undergo PET/CT scan over 20-30 minutes. Beginning 30 days after PET/CT scan, participants undergo chemotherapy. Participants also undergo interim fluorothymidine F-18 PET/CT scan after completion of course 2 of chemotherapy but before commencement of course 3.
After completion of study treatment, participants are followed for up to 2 years.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorDaniella Ferraro Pinho