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

NCT05781555 | Recruiting

• 1 other identifier: CTP- ALL-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor

Keywords

Tumor; Malignant Tumor; Cancer; Brachytherapy; Alpha emitting radiation; Compassionate treatment

Outcome Measures

Primary Outcomes (1)

• To assess the frequency, severity and causality of acute adverse events.

  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.

  From Day 0 (DaRT insertion )

Secondary Outcomes (1)

• To assess the tumor response to DaRT treatment

  3 months after DaRT seed insertion

Study Arms (1)

DaRT seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Experimental: DaRT seeds

Interventions

Experimental: DaRT seeds 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.

DaRT seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Hadassah Ein Kerem

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Aron Popovzer, MD

  Hadassah University Hospital - Ein Kerem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972237377000; LironD@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 23, 2023
• Study Start: March 22, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-05

Locations

IL (1)