RecruitingNot ApplicableNCT05323253

A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

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

Sponsor

Alpha Tau Medical LTD.

Enrollment

86 participants

Start Date

Sep 21, 2022

Study Type

INTERVENTIONAL

Conditions

Recurrent Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called alpha-lipoic acid (an antioxidant supplement) combined with standard diabetes medications to see if it can better control blood sugar and reduce complications in Type 2 diabetes patients. **You may be eligible if...** - You have Type 2 diabetes - Your blood sugar is not well controlled on current medication - You are 18 or older - You are willing to take the study medication as directed **You may NOT be eligible if...** - You have severe kidney or liver disease - You are pregnant or breastfeeding - You have Type 1 diabetes - You are already taking alpha-lipoic acid Talk to your doctor to see if this trial is right for you.

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

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.

Locations(30)

Banner Health MD Anderson Phoenix

Gilbert, Arizona, United States

Dignity Health Cancer Institute

Phoenix, Arizona, United States

Alliance Dermatology

Phoenix, Arizona, United States

UCLA

Los Angeles, California, United States

Day Star Skin and Cancer Center

DeLand, Florida, United States

Integrity Research Clinical Associates

Delray Beach, Florida, United States

Palm beach Dermatology Group

Delray Beach, Florida, United States

Hollywood Dermatology

Hollywood, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Health South Florida MCI

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Beer Dermatology

West Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Schweiger Dermatology Group

Hackensack, New Jersey, United States

New Mexico Cancer Center

Albuquerque, New Mexico, United States

Bassett Healthcare Network

Cooperstown, New York, United States

Northwell Health

Queens, New York, United States

New York Medical Skin Solutions

Rockaway Park, New York, United States

MDCS Dermatology

Smithtown, New York, United States

West Cancer Center

Germantown, Tennessee, United States

Gulf Coast Cancer Center

Houston, Texas, United States

University Cancer & Diagnostic Center

Houston, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Dermatology of Seattle and Bellevue

Bellevue, Washington, United States

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Rambam Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Belinson-Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05323253

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