Treatment of malignant tumors using alpha radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of Diffusing Alpha Radiation Therapy (DaRT) for patients with malignant tumors who do not qualify for existing clinical trials. It is an open-label, one-arm, prospective study focusing on the frequency and severity of acute adverse events related to DaRT treatment, as well as the tumor response assessed three months post-treatment. The study aims to provide compassionate use of this innovative therapy to improve outcomes for patients with limited options.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hadassah Ein Kerem
  Jerusalem, Israel Recruiting

Study contacts

• Principal investigator: Aron Popovzer, MD — Hadassah University Hospital - Ein Kerem
• Study coordinator: Liron Dimnik
• Email: LironD@alphatau.com
• Phone: +972237377000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.