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Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients

Study acronym: DaRT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study description shortened, about 1 wordv7
  2. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Dec 2025 to Dec 2026
    • Start date changed from estimate of Dec 2025 to Jan 1, 2026
    • Site details revised at 11 of 11 sites
    • Study title expanded, about 5 words
  3. Site contacts updated at 2 of 11 sitesv5
  4. Study sites: 1 to 11v4
  5. Start date: Dec 2024 to Dec 2025v3
  6. Study description shortened, about 1 wordv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06615635
Lead Sponsor Alpha Tau Medical LTD.
Conditions
(from sponsor)		 Squamous Cell Carcinoma, Alpha Radiation, Immunocompromised, Carcinoma, Squamous, Skin Cancer, Brachytherapy
Related terms Carcinoma, Squamous Cell, Skin Neoplasms
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov