NCT05657743

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer

Detailed description

This is a Prospective, interventional, open label, single arm, multiple center study. The study is designed to evaluate the feasibility and safety of the DaRT seeds for the treatment of advanced pancreatic cancer. The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 3 months. The total duration of the study will be 3 months from the DaRT insertion procedure. 15 patients with advanced pancreatic cancer will be recruited by the investigational site. Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 3 months post insertion

Conditions

• Pancreatic Cancer
• Unresectable Pancreatic Cancer
• Metastatic Pancreatic Cancer
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)	An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

Timeline

• Start date: 2023-08-16
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2022-12-20
• Last updated: 2025-12-08

Locations

2 sites across 1 country: Israel