Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas

To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on
fresh tumor samples obtained by core needle biopsy from patients planned to receive routine
care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the
pancreas.

Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent and authorization
for release of health information for research

2. ≥ 18 years old at time of consent

3. Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received
prior combination chemotherapy. Exception: prior adjuvant chemoradiation with
fluorouracil or gemcitabine is allowed.

4. Patients considered for routine care treatment with gemcitabine and nab-paclitaxel
(allowed to receive other experimental therapy with gem/nab backbone if participating
in another clinical trial)

5. Measurable disease by RECIST v1.1 criteria

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

7. Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for
research purposes

8. Women are eligible to participate if they are of non-childbearing potential or have
documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of
the start of protocol treatment.

9. Women and men of childbearing potential must agree to use adequate, highly effective
contraceptive measures during protocol treatment

10. Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) < 1.2,
Partial thromboplastin time (PTT) in normal range, Cr < 2.0, Total bilirubin < 2
times upper limit normal (ULN), transaminases < 5 times ULN

Exclusion Criteria:

1. History of abnormal bleeding with minor procedures or documented platelet aggregation
disorder such as VonWillebrand disease

2. Women who are pregnant or breastfeeding