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

Inclusion Criteria:

• Subjects with histopathological confirmation of primary or secondary malignantcutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial softtissue 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 (includingmargins) by the DaRT seeds

• Brachytherapy indication validated by a multidisciplinary team

• Patients who have either failed first-line treatment, or are medically unfit forstandard of care (surgery, external-beam radiation therapy or chemotherapy), orrefuse 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 ofnegative pregnancy test and are required to use an acceptable contraceptive methodto prevent pregnancy for 3 months after brachytherapy.

• Subjects are willing to sign an informed consent form.

Exclusion Criteria:

• Subject has a tumor of Keratoacanthoma histology.

• Known hypersensitivity to any of the components of the treatment.

• Clinically significant cardiovascular disease, e.g. cardiac failure of New YorkHeart Association classes III-IV, uncontrolled coronary artery disease,cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history ofmyocardial infarction in the last 12 months.

• Any medical or psychiatric illness which in the opinion of the investigator wouldcompromise the patient's ability to tolerate this treatment or interfere with thestudy endpoints.

• Patients undergoing systemic immunosuppressive therapy excepting intermittent, briefuse of systemic corticosteroids

• Patient requires treatment which may conflict with the endpoints of this studyincluding evaluation of response or toxicity of DaRT

• Volunteers participating in another interventional study in the past 30 days whichmight conflict with the endpoints of this study or the evaluation of response ortoxicity of DaRT.

• Patients must agree to use adequate contraception (vasectomy or barrier method ofbirth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.

• High probability of protocol non-compliance (in opinion of investigator).

• Subjects not willing to sign an informed consent.

• Women who are pregnant or breastfeeding.