Tests a radiation device inside skin tumors in adults with skin cancer
Tests a small radiation-emitting device placed inside skin tumors in adults with skin cancer.
Plain-language title generated from the registry record
Registry title: Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors
Key facts
- Where
- Grenoble and Lyon, FranceSee the 2 sites
Where in France
- CHU Grenoble AlpesGrenoble, FranceTaking people
- Centre Leon BerardLyon, FranceTaking 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
- NCT04068155
- Record updated
- 16 June 2026
- Original description
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous TumorsRead full original descriptionShow less
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Inclusion: Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:; SCC; BCC; Lentigo maligna melanoma (Dubreuilh melanoma); Carcinosarcoma; Acceptable tumor locations include the following:; Skin (facial, scalp, extremities, torso); Lips; Eyelids; Subjects with a tumor size ≤ 7 centimeters in the longest diameter; Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds; 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; 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; Metastatic disease (according to the TNM staging system - M1 patients are excluded); 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 with histology of one of the following:; Keratoacanthoma; Merkel cell carcinoma; Sarcoma other than carcinosarcoma; 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.