Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT05323253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05323253
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 21, 2022 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Apr 2027 (Estimated)
- Last update posted
- Jun 16, 2026
2022 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 10
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Health MD Anderson Phoenix | Gilbert | Arizona | 85234 | — |
| Dignity Health Cancer Institute | Phoenix | Arizona | 85004 | — |
| Alliance Dermatology | Phoenix | Arizona | 85032 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Day Star Skin and Cancer Center | DeLand | Florida | 32720 | — |
| Integrity Research Clinical Associates | Delray Beach | Florida | 33445 | — |
| Palm beach Dermatology Group | Delray Beach | Florida | 33484 | — |
| Hollywood Dermatology | Hollywood | Florida | 33021 | — |
| University of Miami | Miami | Florida | 33101 | — |
| Baptist Health South Florida MCI | Miami | Florida | 33176 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Beer Dermatology | West Palm Beach | Florida | 33401 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| 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 | — |
| Northwell Health | Queens | New York | 11375 | — |
| New York Medical Skin Solutions | Rockaway Park | New York | 11694 | — |
| MDCS Dermatology | Smithtown | New York | 11787 | — |
| Gulf Coast Cancer Center | Houston | Texas | 77008 | — |
| University Cancer & Diagnostic Center | Houston | Texas | 77089 | — |
| Dermatology of Seattle and Bellevue | Bellevue | Washington | 98004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05323253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 16, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05323253 live on ClinicalTrials.gov.