Tests the DaRT alpha radiation device for superficial skin and soft tissue cancers
Tests a device placing radiation inside skin, mouth lining, or soft tissue tumors in adults.
Plain-language title generated from the registry record
Registry title: Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
Key facts
- Where
- Haifa, IsraelSee the site
Where in Israel
- Rambam Health Care CampusHaifa, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alpha Tau Medical LTD.
- Trial code
- NCT03889899
- Record updated
- 2 December 2025
- Original description
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasiaRead full original descriptionShow less
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Inclusion: Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma; Subjects with a tumor size ≤ 7 centimeters in the longest diameter; Measurable disease according to RECIST v1.1; Subjects over 18 years old; Subjects' ECOG Performance Status Scale is < 2; Subjects' life expectancy is more than 6 months; Platelet count ≥100,000/mm3; International normalized ratio of prothrombin time ≤1.8; Creatinine ≤1.9 mg/dL; Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test; Subjects are willing to sign an informed consent form.
Exclusion: Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids; Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.); Subject has a tumor of Keratoacanthoma histology; Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT; High probability of protocol non-compliance (in opinion of investigator); Subjects not willing to sign an informed consent; Women who are pregnant or breastfeeding.