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

Prior treatment

• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.

Other illness

• 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.).

Other

• 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.

• 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