NCT03737734Active, not recruiting
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
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 6 Apr 2026
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)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Nov 2018
- Start date
- 31 Dec 2018
- Primary completion date
- Dec 2026
- Lead sponsor
- Alpha Tau Medical LTD.
- Diseases
- Head and neck cancer, Sarcoma
- NCT number
- NCT03737734
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 31 Dec 2018 to the primary completion date, Dec 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)
- 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.
- Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
- 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 |
|---|---|---|---|
| Davidof Cancer Institution at the Rabin Medical Center Israel Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.