Actively Recruiting
Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors
Led by Alpha Tau Medical LTD. · Updated on 2026-04-06
100
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
CONDITIONS
Official Title
Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with any malignancy
- Subjects with a tumor size 64 7 centimeters in the longest diameter
- Subjects over 18 years old
- Subjects' life expectancy is more than 6 months
- Women of childbearing potential must have a negative pregnancy test and use acceptable contraception for 3 months after treatment
- Subjects or their surrogate decision maker must be willing to sign an informed consent form
You will not qualify if you...
- Known hypersensitivity to any treatment components
- Clinically significant cardiovascular disease including NYHA class III-IV heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or recent myocardial infarction within 12 months
- Medical or psychiatric illness that could prevent tolerating treatment or interfere with study outcomes
- Participation in another interventional study within the past 30 days that conflicts with this study
- Failure to agree to use adequate contraception before, during, and for 3 months after therapy
- High risk of not following the study protocol
- Unwillingness to sign informed consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hadassah Ein Kerem
Jerusalem, Israel
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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