NCT03889899Recruiting
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Mar 2019
- Start date
- 21 Oct 2020
- Primary completion date
- Jun 2026
- Lead sponsor
- Alpha Tau Medical LTD.
- Diseases
- Head and neck cancer, Sarcoma
- NCT number
- NCT03889899
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 21 Oct 2020 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
Other illness
- 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.)
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.