NCT03889899 Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
| NCT ID | NCT03889899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Skin Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-10-21 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2020-10-21 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Eligibility Criteria
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.
Contact & Investigator
Tomer Charas, MD
PRINCIPAL INVESTIGATOR
Radiotherapy unit at Rambam Health Care Campus, Israel
Frequently Asked Questions
Who can join the NCT03889899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skin Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03889899 currently recruiting?
Yes, NCT03889899 is actively recruiting participants. Contact the research team at LironD@alphatau.com for enrollment information.
Where is the NCT03889899 trial being conducted?
This trial is being conducted at Haifa, Israel.
Who is sponsoring the NCT03889899 clinical trial?
NCT03889899 is sponsored by Alpha Tau Medical LTD.. The principal investigator is Tomer Charas, MD at Radiotherapy unit at Rambam Health Care Campus, Israel. The trial plans to enroll 30 participants.
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