Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.

This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline: 1. Locally advanced 2. Metastatic. Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.