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.
Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
Measurable disease according to RECIST v1.1.
Subjects over 18 years old.
Disqualifiers
Subject has a tumor of Keratoacanthoma histology.
Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
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.
Trial design
Treatments tested in this trial
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov