Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.
About this trial
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Eligibility criteria
Qualifiers
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
Disqualifiers
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 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.
Trial design
Treatments tested in this trial
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov