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Diffusing Alpha Radiation Therapy for Malignant Tumors

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Study Aim

This study aims to assess the frequency and severity of acute adverse events in individuals receiving diffusing alpha radiation therapy for malignant tumors.

What is being tested

Experimental: DaRT seeds

Device
Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorAlpha Tau Medical LTD.
Study ContactLiron Dimnik
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 22, 2023

Actual date on which the first participant was enrolled.

This study explores a new way to help patients with serious tumors who cannot join other research studies. It looks at a treatment called Diffusing Alpha Radiation Therapy (DaRT), which aims to find out if this method is safe and effective. This study is especially important for those who have limited options for participating in existing trials. By testing DaRT, researchers hope to provide new insights and possibly improve treatment options for these individuals. Participants in this study receive the DaRT treatment, and researchers closely monitor them to see if there are any side effects. The focus is on understanding how often and how severe these side effects might be. Additionally, the study evaluates how well the treatment works by checking the size of the tumors three months after starting DaRT. This involves using a set of criteria known as RECIST to see if the tumors have shrunk. The findings from this study could lead to better treatment strategies for patients with certain types of cancer.

Official TitleA Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy
NCT05781555
Principal SponsorAlpha Tau Medical LTD.
Study ContactLiron Dimnik
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hadassah Ein Kerem

Jerusalem, IsraelOpen Hadassah Ein Kerem in Google Maps
Recruiting
One Study Center
Diffusing Alpha Radiation Therapy for Malignant Tumors | PatLynk