A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Alpha Tau Medical LTD.
- Study ID
- NCT05323253
- Status
- Recruiting
Conditions
- Recurrent Squamous Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- DaRT seeds — DEVICEDaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.
Study Details
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.
Key Dates
- Start date
- Sep 21, 2022
- Status verified
- May 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 86 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: DaRT seedsDaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.
Primary Outcome Measure
Objective Response Rate [ Time Frame: From Day 14 until 52 weeks ]
Central Contacts
- Liron Dimnik+972-2-3737-210
- Aviya Hoida+972-2-3737-210
Locations (25)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner Health MD Anderson Phoenix | Gilbert | Arizona | 85234 | Pamela Urban |
| Alliance Dermatology | Phoenix | Arizona | 85032 | |
| Dignity Health Cancer Institute | Phoenix | Arizona | 85004 | - |
| UCLA | Los Angeles | California | 90095 | |
| Day Star Skin and Cancer Center | DeLand | Florida | 32720 | |
| Integrity Research Clinical Associates | Delray Beach | Florida | 33445 | John Strasswimmer, MD |
| Palm beach Dermatology Group | Delray Beach | Florida | 33484 | |
| Hollywood Dermatology | Hollywood | Florida | 33021 | |
| Baptist Health South Florida MCI | Miami | Florida | 33176 | |
| University of Miami | Miami | Florida | 33101 | |
| Moffitt Cancer Center | Tampa | Florida | 33612 | - |
| Beer Dermatology | West Palm Beach | Florida | 33401 | Monica Dunn |
| Emory University | Atlanta | Georgia | 30308 | Zachary Buchwald, MD Stacie Hitchcook |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | |
| Schweiger Dermatology Group | Hackensack | New Jersey | 07601 | |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | |
| Bassett Healthcare Network | Cooperstown | New York | 13326 | Peggy Cross |
| Northwell Health | Queens | New York | 11375 | - |
| New York Medical Skin Solutions | Rockaway Park | New York | 11694 | |
| MDCS Dermatology | Smithtown | New York | 11787 | Snehal Amin, MD |
| West Cancer Center | Germantown | Tennessee | 38138 | - |
| Gulf Coast Cancer Center | Houston | Texas | 77008 | Alpesh Desai, MD |
| University Cancer & Diagnostic Center | Houston | Texas | 77089 | |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | - |
| Dermatology of Seattle and Bellevue | Bellevue | Washington | 98004 |
Find similar trials in Gilbert, AZ
Related Studies
- Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCCPHASE1 · Recruiting · University of Chicago · Chicago, Illinois