NCT06755359

Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer

A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .

Detailed description

This study will be a prospective, interventional, open label, single arm, multiple center study. Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.

Conditions

• Pancreatic Cancer
• Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DEVICE	Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)	Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2025-01-01
• Last updated: 2025-12-02

Locations

12 sites across 1 country: France