Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in patients with borderline resectable or locally advanced, pancreatic adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Alovudine

Criteria

Inclusion Criteria:

• Patients with histologically confirmed pancreatic adenocarcinoma (resectable, 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 over 18 years old and capable and willing to provide informed consent.

• Patients must have measurable disease (by RECIST 1.1 criteria)

• Patients must have an ECOG performance status of 0-3 (restricted to ECOG 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 (or FDG if for research) 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 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.

Exclusion Criteria:

• 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

• Patients must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed.(>200kg or 440lbs)