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 2025-02-07
56
Participants Needed
1
Research Sites
262 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 malignant cutaneous, oral mucosal, or superficial soft tissue tumor within 6 months
- Tumor size 7 centimeters or less in longest diameter
- Lesion amenable to complete coverage by DaRT seeds
- Brachytherapy indication approved by multidisciplinary team
- Failed first-line treatment, medically unfit for, or refused standard care
- Measurable disease per RECIST v1.1
- Age 18 years or older
- ECOG Performance Status less than 2
- Life expectancy greater than 6 months
- Platelet count at least 100,000/mm3
- White blood cell count at least 3500/µL, granulocytes at least 1500/µL
- AST and ALT less than or equal to 2.5 times upper limit of normal
- 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 and use of contraception for 3 months after treatment
- Willingness to sign informed consent
You will not qualify if you...
- Tumor with Keratoacanthoma histology
- Known allergy to any treatment components
- Significant cardiovascular disease such as severe heart failure, uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, uncontrolled hypertension, or heart attack within past 12 months
- Medical or psychiatric conditions interfering with treatment or study endpoints
- Ongoing systemic immunosuppressive therapy except brief corticosteroid use
- Treatments conflicting with study evaluation
- Participation in other interventional studies within past 30 days
- Inability or unwillingness to use adequate contraception during and 3 months after study
- High risk 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
Sharett institute, Hadassah Medical Center - Ein-Kerem
Jerusalem, Israel, 91120
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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