Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

Prior treatment

• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
• Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.

Other illness

• Known hypersensitivity to any of the components of the treatment.
• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.

Other

• Subject has a tumor of Keratoacanthoma histology.
• Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT
• 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 primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.
• Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
• Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
• Brachytherapy indication validated by a multidisciplinary team
• Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
• 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.
• WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
• AST and ALT ≤ 2.5 X ULN
• 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 and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
• Subjects are willing to sign an informed consent form.