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NOT YET RECRUITING
NCT06615635
NA

Clinical Study Protocol for Cutaneous SCC for Immunocompromised Patients

Sponsor: Alpha Tau Medical LTD.

View on ClinicalTrials.gov

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.

Official title: A Pivotal, 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-12

Completion Date

2026-12

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

DEVICE

DaRT 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