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NCT05323253 · ClinicalTrials.gov registry record · NA
A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma
A NA study of Recurrent Squamous Cell Carcinoma, sponsored by Alpha Tau Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT05323253: Recruiting NA study of Recurrent Squamous Cell Carcinoma, sponsored by Alpha Tau Medical.
NCT05323253 is a NA study of Recurrent Squamous Cell Carcinoma that is actively recruiting participants, run by Alpha Tau Medical. The registered enrollment target is 86 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05323253, a NA study of Recurrent Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Alpha Tau Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Objective Response Rate (ORR) of DaRT as treatment for Recurrent SCC established by the confirmed Best Overall Response (BOR), with confirmation at least 4 weeks after initial assessment
Conditions Studied
Interventions
- DEVICE DaRT seeds
Study Locations (20)
Florida
- Day Star Skin and Cancer Center - DeLand
- Integrity Research Clinical Associates - Delray Beach
- Palm beach Dermatology Group - Delray Beach
- Hollywood Dermatology - Hollywood
- University of Miami - Miami
- Baptist Health South Florida MCI - Miami
- Moffitt Cancer Center - Tampa
- Beer Dermatology - West Palm Beach
New York
- Bassett Healthcare Network - Cooperstown
- Northwell Health - Queens
- New York Medical Skin Solutions - Rockaway Park
- MDCS Dermatology - Smithtown
Arizona
- Banner Health MD Anderson Phoenix - Gilbert
- Dignity Health Cancer Institute - Phoenix
- Alliance Dermatology - Phoenix
California
- UCLA - Los Angeles
Georgia
- Emory University - Atlanta
Minnesota
- Mayo Clinic Rochester - Rochester
New Jersey
- Schweiger Dermatology Group - Hackensack
New Mexico
- New Mexico Cancer Center - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT05323253 shows while recruiting
NCT05323253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Recurrent Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which DaRT seeds is the first listed.
NCT05323253 names 20 study sites across 8 states, led by Florida, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT05323253 about?
NCT05323253 is a clinical study titled "A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma". 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 wel...
What is the current status of trial NCT05323253?
This trial is currently recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2022-09-21. Estimated completion is 2025-12.
What conditions does trial NCT05323253 study?
This clinical trial studies the following conditions: Recurrent Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05323253?
The interventions under investigation include: DaRT seeds (DEVICE).
Who is sponsoring clinical trial NCT05323253?
This trial is sponsored by Alpha Tau Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05323253 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05323253's enrollment target sits among peer trials
86 976th of 2000 higher than 1,021 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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