Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors

This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

NCT Number	NCT05781555
Lead Sponsor	Alpha Tau Medical LTD.
Conditions	Malignant Tumor
Enrollment	100 participants
Start Date	2023-03-22
Primary Completion	2027-04 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-16