Fluorothymidine F-18 PET / CT in Predicting Outcome in Participants with Locally Advanced Pancreatic Cancer
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.
- Patients with histologically confirmed pancreatic adenocarcinoma (borderline resectable or locally advanced disease at presentation) are eligible for the study
- Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study
- Patients must be capable and willing to provide informed consent
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)
- Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to FLT PET/CT and FDG PET/CT imaging per institution’s standard of care; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria; * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Medically stable as judged by patient’s physician
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FLT or FDG are NOT eligible
- Ability to understand and the willingness to sign a written informed consent
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan
- Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study
- Patient must NOT be pregnant or breast-feeding
- Patients have no clinical evidence of distant metastatic disease
Locations & Contacts
Contact: Daniella Ferraro Pinho
Trial Objectives and Outline
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 borderline resectable or locally advanced pancreatic adenocarcinoma.
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 borderline resectable or locally advanced pancreatic adenocarcinoma.
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.
Trial Phase & Type
UT Southwestern / Simmons Cancer Center-Dallas
Daniella Ferraro Pinho
Secondary IDs NCI-2018-01082
Clinicaltrials.gov ID NCT03318497