Recruiting nowN/AAges 18 Years and up
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
Sponsor: Alpha Tau Medical LTD. · NCT03889899 on ClinicalTrials.gov ↗
Conditions studied
Skin CancerMucosal Neoplasm of Oral CavitySoft Tissue Neoplasm
What it tests
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)device
Where it's running1 site
1 international site
- Recruiting now
RAMBAM Health Care Campus
Haifa, Israel 3109601
- Tomer Charas, MD(contact)+972-4-777-6505[email protected]
- Tomer Charas, MD(principal investigator)
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
Inclusion Criteria: * 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 Criteria: * Subject has a tumor of Keratoacanthoma histology. * 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.) * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * 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.
Updated 2025-12-02 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.