Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Key facts
- Where
- Jerusalem, IsraelSee the site
Where in Israel
- Sharett institute, Hadassah Medical Center - Ein-KeremJerusalem, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alpha Tau Medical LTD.
- Trial code
- NCT04534127
- Record updated
- 16 June 2026
- Original description
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasiaRead full original descriptionShow less
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Inclusion: 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.
Exclusion: 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; 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; 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.