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NCT04377360 · ClinicalTrials.gov registry record · NA
Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin & Superficial Soft Tissue Tumors
A NA study, sponsored by Alpha Tau Medical.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT04377360: Completed NA study, sponsored by Alpha Tau Medical.
NCT04377360 is a NA study that has completed, run by Alpha Tau Medical. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04377360, a NA study, has completed, sponsored by Alpha Tau Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a single-institution pilot feasibility trial in which 10 subjects will be enrolled. The primary objectives are is to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using DaRT (Alpha Tau Medical, Tel Aviv, Israel), a form of interstitial brachytherapy which uses a novel radioisotope delivery system, as well as to determine the frequency and severity of acute adverse events. Secondary objectives will include assessments of radiotherapy-related adverse events, tumor response, radiation safety, stability of device placement, and associations with quality of life.
Primary Outcome
To explore feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using Diffusing Alpha-emitter Radiation Therapy (DaRT). Feasibility will be determined by successful delivery of radiation by DaRT to the malignant tumor. If an attempt to place the DaRT is unsuccessful, this patient will be considered a feasibility failure. A feasibility failure may be due to inability to execute the workflow of pre-brachytherapy imaging, treatment planning, device procuremen
Interventions
- RADIATION Diffusing Alpha-emitter Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2022-03-28 |
| Phase | NA |
What the finished NCT04377360 record still lists
NCT04377360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Diffusing Alpha-emitter Radiation Therapy is the first listed.
NCT04377360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04377360 about?
NCT04377360 is a clinical study titled "Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin & Superficial Soft Tissue Tumors". This is a single-institution pilot feasibility trial in which 10 subjects will be enrolled. The primary objectives are is to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using DaRT (Alpha Tau Medical, Tel Aviv, Israel), a form of interstiti...
What is the current status of trial NCT04377360?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2020-01-06. Estimated completion is 2022-03-28.
What interventions are being tested in trial NCT04377360?
The interventions under investigation include: Diffusing Alpha-emitter Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04377360?
This trial is sponsored by Alpha Tau Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04377360's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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