Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy
device that provides unidirectional radiation which utilizes active components
(Palladium-103) of standard devices in a novel configuration.This pilot study may benefit
pancreatic cancer patients by reducing the radiation dose to adjacent critical structures,
while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The
appropriate dose and local control rate will be recorded the primary endpoint in order to
provide an efficacy assessment.

Inclusion Criteria:

- • Subject signed inform consent

- Age > 18 years

- Not pregnant or breast feeding

- Patient capable of undergoing anesthesia

- Patient selected to undergo Whipple procedure or distal pancreatectomy

- Patient does not have metastatic disease

- Patients will have close margins

- No prior radiation therapy to the region for separate cancer

- Confirmed diagnosis of borderline resectable or locally advanced pancreatic
adenocarcinoma

- Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)

- Chemotherapy was administered for 2-6 cycles with any combination of the
following agents:

- Gemcitabine + nb-paclitaxel

- FOLFIRINOX

- Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or
SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)

- up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine,
or infusional 5-fluorouracil

Exclusion Criteria:

- Not surgical candidate

- Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin
cancer

- An IRE candidate (IRE is Percutaneous irreversible electroporation)

- Recurrent or previously resected tumors

- Documented History of Alcoholism and or drug abuse

- Participant in other clinical trials