Clinical Trial

Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma

Active, Not Recruiting
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Summary
This is a multi-center clinical study enrolling up to 86 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, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2022-04-11; most recent amendment 2026-06-15.
Status change: Recruiting → Active, Not Recruiting 2026-06-15
Status change: Not Yet Recruiting → Recruiting 2022-11-21
Trial Details
NCT Number NCT05323253
Lead Sponsor Alpha Tau Medical LTD.
Conditions Recurrent Squamous Cell Carcinoma
Enrollment 86 participants
Start Date 2022-09-21
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-16