Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors

Recruiting now · Not applicable

Conditions studied: Malignant Tumor

In brief

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.

Key facts

Study ID

NCT05781555

Run by

Alpha Tau Medical LTD.

People needed

100

Starts

2023-03-22

Expected to finish

2027-04-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with any malignancy
• Subjects with a tumor size ≤ 7 centimeters in the longest diameter
• Subjects over 18 years old
• Subjects' life expectancy is more than 6 months
• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment.
• Subjects/Surrogate decision maker are willing to sign an informed consent form

You may not qualify if…

• Known hypersensitivity to any of the components of the treatment.
• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
• 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.
• Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
• High probability of protocol non-compliance (in opinion of investigator).
• Subjects/Surrogate decision maker not willing to sign an informed consent.
• Women who are pregnant or breastfeeding.

Where it is running

• Hadassah Ein Kerem — Jerusalem, Israel (enrolling)

Full record on ClinicalTrials.gov

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