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

Alpha Tau Medical

Status

Enrolling

Conditions

Malignant Tumor

Treatments

Device: Experimental: DaRT seeds

Study type

Interventional

Funder types

Industry

Identifiers

NCT05781555

CTP- ALL-00

Details and patient eligibility

About

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.

Full description

This is an Open label, one arm, prospective study for Compassionate use for the treatment of malignant tumors. The study objectives are to collect data on the safety and efficacy of DaRT among patients who do not fit the entry of existing investigational trials.

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.