Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Trial Parameters
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Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Eligibility Criteria
Inclusion Criteria: * 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