A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors

Launched by ALPHA TAU MEDICAL LTD. · Mar 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Diffusing Alpha Radiation Therapy (DaRT) for people with malignant tumors, which are harmful growths in the body. The main goal of the study is to see how often and how seriously patients experience side effects from this treatment. Researchers will also look at how well the tumors respond to the therapy three months after receiving it. This study is currently recruiting participants who are adults over 18 years old and have certain types of tumors that are 7 centimeters or smaller.

To be eligible for the trial, participants must have a diagnosis of cancer and be expected to live for at least six more months. Women who can become pregnant need to have a negative pregnancy test and agree to use birth control during the study and for three months afterward. It’s important that potential participants discuss the study with their doctors and provide informed consent before joining. This study is designed to gather important information that may help improve treatment options for patients with malignant tumors in the future.

Gender

ALL

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.