Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

This study is to prospectively determine whether there is a predictive relationship in RPC
between pre-operative radiomic imaging features and pathologic tumor heterogeneity,
delineated by gene-expression-based RSI and histologic measures of hypoxia measured by Glut-1
and CA-IX as well as the degree of pimonidazole staining.

Inclusion Criteria:

- 18 years of age and older who have biopsy-proven resectable pancreatic cancer

- Participants must have a histological diagnosis of pancreatic head ductal
adenocarcinoma at least ≥ 1 cm from ampula.

- Participants must be able to undergo all 3 imaging modalities.

- Participants' medical statuses must be considered appropriate for surgery and for
general anesthesia.

- Female participants and female partners of male participants undergoing optional
PET-CT or CT pancreatic protocol scan cannot be pregnant or nursing, as confirmed by
serum pregnancy test if the patient is a woman of child-bearing potential.

- All female participants of child-bearing potential must agree to use birth control,
including oral, injectable, or mechanical contraception, abstinence, or vasectomy for
30 days following pimonidazole administration.

- Adequate kidney and liver function as assessed by laboratory studies. Laboratory
studies must be completed within 28 days prior to pimonidazole administration;

- Must be capable of providing informed consent and demonstrate a willingness to comply
with all the study procedures and visits;

- Must be able to undergo MRI scans without having a pacemaker or other indwelling
metal, which would contraindicate the scan.

- Have an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Participants who are contraindicated for MRI or gadolinium contrast agents.

- If the patient has an iodine contrast allergy, they must be able to take standard
pre-medications so they can safely undergo a CT scan.

- Participants with a known active cancer with a prognosis that would contraindicate a
curative intent pancreatic resection.

- Participants with depressed liver function, as assessed with a screening liver
function test yielding serum ALT or AST greater than the IULN or total bilirubin
greater than 2 mg/dL.

- Presence of any other co-existing condition, which, in the judgment of the
investigator, might increase the risk to the patient.