Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT; Computed Tomography; Positron Emission Tomography; Laboratory Biomarker Analysis
Intervention description: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.; Undergo PET/CT; Undergo PET/CT; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle.
Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic adenocarcinoma; 18F-FLT; FLT; Locally advanced pancreatic adenocarcinoma; Borderline resectable pancreatic adenocarcinoma; resectable pancreatic adenocarcinoma

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.
    

Eligibility 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)