Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors

Recruiting now · Not applicable

Conditions studied: Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis

In brief

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Key facts

Study ID

NCT04068155

Run by

Alpha Tau Medical LTD.

People needed

80

Starts

2022-04-01

Expected to finish

2028-01-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subject has a tumor with histology of one of the following:
• Keratoacanthoma
• Merkel cell carcinoma
• Sarcoma other than carcinosarcoma
• 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.).
• 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.

Where it is running

• CHU Grenoble Alpes — Grenoble, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)

Full record on ClinicalTrials.gov

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