Study on Safety and Feasibility of Intratumoral Alpha Radiation Device for Advanced Pancreatic Cancer Treatment

What this Trial Is About

Researchers are evaluating a unique method for treating advanced pancreatic cancer using an intratumoral diffusing alpha radiation emitter device called DaRT. This prospective, interventional, open-label, single-arm, multi-center study aims to assess the feasibility and safety of placing these DaRT seeds directly into pancreatic tumors. The study plans to enroll 15 patients with advanced pancreatic cancer who meet specific eligibility criteria, including prior chemotherapy or unsuitability for further chemotherapy, and tumors not suitable for radical surgery or when surgery is declined. Participants will undergo a screening period followed by the DaRT seed insertion procedure. After the insertion, there will be an acute follow-up phase lasting between 4 to 8 weeks to monitor immediate outcomes, followed by a long-term follow-up phase of 3 months. The total study duration from the DaRT insertion is 3 months. The DaRT seeds consist of radioactive sources containing Ra-224, which release short-lived alpha-emitting atoms directly into the tumor to target cancer cells. During the study, participants will be closely monitored through various assessments including safety checks for adverse events up to 3 months post-procedure. Effectiveness of the treatment will be evaluated at 1 month and 3 months after insertion, as well as immediately after the procedure. Patients will be assessed using measurable lesion criteria according to RECIST version 1.1, laboratory tests for blood counts and organ function, and overall health status evaluations. The trial includes monitoring for treatment feasibility, safety, and efficacy with a total commitment of approximately 3 months per participant.

Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer (Feasibility and Safety)