RecruitingNot ApplicableNCT06615635

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

A Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma


Sponsor

Alpha Tau Medical LTD.

Enrollment

28 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called DaRT seeds for people with alpha radiation, brachytherapy, and other related conditions. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDaRT seeds

Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients


Locations(11)

Banner Health

Gilbert, Arizona, United States

Us Dermatology Parthners

Phoenix, Arizona, United States

Alliance Dermatology

Phoenix, Arizona, United States

Integrity Research Clinical Associates

Boca Raton, Florida, United States

Hollywood Dermatology

Hollywood, Florida, United States

Palm Beach Dermatology Group

Palm Beach, Florida, United States

Day Star Skin Cancer Center

Poinciana, Florida, United States

Emory University

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

Bassett Healthcare

Cooperstown, New York, United States

Hadassah Medical Center

Jerusalem, Israel

View Full Details on ClinicalTrials.gov

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NCT06615635


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