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Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion pushed from Apr 2026 to Apr 2027v7
  2. Study title shortened, about 2 wordsv6
  3. Primary completion date: Apr 2025 to Apr 2026
    • Study completion date: Apr 2025 to Apr 2027
    v5
  4. Primary completion date: Apr 2024 to Apr 2025
    • Study completion date: Feb 2025 to Apr 2025
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2023 to Mar 22, 2023
    v3
  6. Primary endpoint revised
    • Secondary endpoint revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
Trial Details
NCT Number NCT05781555
Lead Sponsor Alpha Tau Medical LTD.
Conditions
(from sponsor)		 Malignant Tumor
Related terms Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov