Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05781555

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Hadassah Ein Kerem

Jerusalem, Israel

Actively Recruiting

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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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