Clinical Study Protocol for Cutaneous SCC for Immunocompromised Patients
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Alpha Tau Medical LTD.
- Study ID
- NCT06615635
- Status
- Not Yet Recruiting
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Conditions
- Alpha Radiation
- Brachytherapy
- Carcinoma, Squamous
- Immunocompromised
- Skin Cancer
- Squamous Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- DaRT seeds — DEVICEDiffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
Study Details
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.
Key Dates
- Start date
- Dec 31, 2025
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: DaRT seedsDiffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
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 (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner Health | Gilbert | Arizona | 35234 | |
| Alliance Dermatology | Phoenix | Arizona | 85032 | |
| Us Dermatology Parthners | Phoenix | Arizona | 85006 | |
| Integrity Research Clinical Associates | Boca Raton | Florida | 33445 | John Strasswimmer, Md Renzo Puente |
| Hollywood Dermatology | Hollywood | Florida | 33201 | Lucy Vargas |
| Palm Beach Dermatology Group | Palm Beach | Florida | 33848 | |
| Day Star Skin Cancer Center | Poinciana | Florida | 33445 | Neil Sandhu, MD |
| Emory University | Atlanta | Georgia | 30308 | |
| Mayo Clinic | Rochester | Minnesota | 55905 | |
| Bassett Healthcare | Cooperstown | New York | 13326 | Peggy Cross |
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