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

NCT ID: NCT05781555

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed 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.

Conditions

Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DaRT seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Group Type: EXPERIMENTAL

Experimental: DaRT seeds

Intervention Type: DEVICE

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.

Interventions

Experimental: DaRT seeds

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha Tau Medical LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aron Popovzer, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital - Ein Kerem

Locations

Hadassah Ein Kerem

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Liron Dimnik

Role: CONTACT

LironD@alphatau.com

+972237377000

Facility Contacts

Aron Popovzer, MD

Role: primary

Aronp@hadassah.org.il

Hanna Lea Knafou

Role: backup

hannalea@hadassah.org.il

972-2-6776709

Other Identifiers

CTP- ALL-00

Identifier Type: -

Identifier Source: org_study_id