Treatment of malignant tumors using alpha radiation therapy

A Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy

This study is testing a new type of radiation therapy for patients with malignant tumors who have few treatment options to see if it can help their tumors shrink and if it's safe to use.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alpha Tau Medical LTD. (industry)
• Locations: 1 site (Jerusalem)
• Trial ID: NCT05781555 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with any malignancy and tumor sizes of 7 centimeters or less.

Not a fit: Patients with significant cardiovascular disease or those who are hypersensitive to treatment components may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with malignant tumors who have exhausted other treatment avenues.

How similar studies have performed: While this approach is innovative, similar studies using alpha radiation therapy have shown promise, indicating potential for success.

Eligibility 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.

Where this trial is running

Jerusalem

• Hadassah Ein Kerem — Jerusalem, Israel (RECRUITING)

Study contacts

• Principal investigator: Aron Popovzer, MD — Hadassah University Hospital - Ein Kerem
• Study coordinator: Liron Dimnik

Conditions: Malignant Tumor, Tumor, Cancer, Brachytherapy, Alpha emitting radiation, Compassionate treatment