Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin & Superficial Soft Tissue Tumors
Completed · Not applicable
Conditions studied: Malignant Skin Tumor, Soft Tissue Tumor, Malignant
In brief
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.
Key facts
- Study ID
- NCT04377360
- Run by
- Alpha Tau Medical LTD.
- People needed
- 10
- Starts
- 2020-01-06
- Expected to finish
- 2022-03-28
- Last updated by the study team
- 2022-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UnityPoint Health - John Stoddard Cancer Center — Des Moines, Iowa, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- West Cancer Center & Research Institute — Germantown, Tennessee, United States
- University Cancer & Diagnostic Center — Houston, Texas, United States
- Dermatology of Seattle and Bellevue — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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