Clinical Trial

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients

Study acronym: DaRT

Recruiting

Summary

This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to: 1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion. 2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months. 3. Assess Local control up to 12 months after DaRT insertion.

Protocol Amendment History 6 amendments

This ClinicalTrials.gov record has been amended 6 times since 2024-09-25; most recent amendment 2026-07-14.

Status change: Not Yet Recruiting → Recruiting 2026-06-15

Trial Details

NCT Number	NCT06615635
Lead Sponsor	Alpha Tau Medical LTD.
Conditions	Squamous Cell Carcinoma, Alpha Radiation, Immunocompromised, Carcinoma, Squamous, Skin Cancer, Brachytherapy
Enrollment	28 participants
Start Date	2026-01-01
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-15