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

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.

Visit 1: Patients will have at least one visit with investigator (or investigator designee)
prior to the study to review clinical history and prior treatment of pancreatic
adenocarcinoma, and to explain the study. Correlative radiology studies including CT, MRI and
18F FDG-PET/CT as per institutional routine clinical care, and any clinically-directed
laboratory tests performed as part of staging must be performed within 30 days of the 18F
FLT-PET/CT

Visit 2 (Optional): The 18F-FDG-PET/CT may be done as a research scan, if the patient is
unable to obtain a clinically-directed 18F-FDG-PET/CT as part of their clinical care or
within 30 days of 18F FLT-PET/CT. The research 18F-FDG-PET/CT, in this instance, will be
identical in procedure to the institution's clinical 18F-FDG-PET/CT. The blood glucose level
will be < 200 mg/dl, before 18F-FDG injection, which is institutional standard clinical
protocol. The following additional patient data will be obtained: histological diagnosis of
primary and/or metastatic disease, date of diagnosis of primary and metastatic disease,
gender, height, weight (for BMI), ECOG score and confirmation of absence of prior treatment.

Visit 3: Day of 18F-FLT-PET/CT: The patient will have an intravenous line placed in the hand
or arm, 18F-FLT-PET/CT will be given by 1-2 minute IV push, and the dose administered will be
approximately 5 mCi (+/- 20% dose). After approximately 60 +/- 10 minutes of uptake time, the
patient will be positioned supine in the PET/CT scanner for standard whole body PET/CT scan
from the skull base to mid-thigh. This scan will take approximately 20-30 min. The window
from FLT PET/CT baseline study to initiation of chemotherapy should be no more than 30 days.

Visit 4: Day of Interim 18F-FLT-PET/CT: The interim 18F FLT-PET/CT will be performed after
the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. The second
18F-FLT-PET/CT study must be performed on the same scanner as the first 18F FLT-PET/CT and
the imaging protocol described in Visit 3 should be closely followed.

Study duration:

Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years
following the end of chemotherapy.

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)