Actively Recruiting
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
Led by Alpha Tau Medical LTD. · Updated on 2025-12-02
30
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
CONDITIONS
Official Title
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological confirmation of primary or secondary malignant cutaneous lesions, oral cavity mucosal tumors, or superficial soft tissue sarcoma
- Tumor size 7 centimeters or less in longest diameter
- Measurable disease according to RECIST v1.1
- Age 18 years or older
- ECOG Performance Status less than 2
- Life expectancy more than 6 months
- Platelet count of at least 100,000/mm3
- International normalized ratio of prothrombin time 1.8 or less
- Creatinine 1.9 mg/dL or less
- Negative pregnancy test for women of childbearing potential
- Willingness to sign informed consent form
You will not qualify if you...
- Tumor with Keratoacanthoma histology
- Significant comorbidities that may interfere with study endpoints (e.g., poorly controlled autoimmune diseases, vasculitis)
- Ongoing systemic immunosuppressive therapy except brief, intermittent corticosteroids
- Participation in another interventional study within the past 30 days that may conflict with this study
- High probability of protocol non-compliance
- Unwillingness to sign informed consent
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
RAMBAM Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
Research Team
L
Liron Dimnik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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