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

Last updated: May 16, 2024
Sponsor: Alpha Tau Medical LTD.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Genitourinary Cancer

Treatment

Experimental: DaRT seeds

Clinical Study ID

NCT05781555
CTP- ALL-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 pregnancytest and are required to use an acceptable contraceptive method to prevent pregnancyfor 3 months after treatment.

  • Subjects/Surrogate decision maker are willing to sign an informed consent form

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to any of the components of the treatment.

  • Clinically significant cardiovascular disease, e.g. cardiac failure of New YorkHeart Association classes III-IV, uncontrolled coronary artery disease,cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history ofmyocardial infarction in the last 12 months.

  • Any medical or psychiatric illness which in the opinion of the investigator wouldcompromise the patient's ability to tolerate this treatment or interfere with thestudy endpoints.

  • Volunteers participating in another interventional study in the past 30 days whichmight conflict with the endpoints of this study or the evaluation of response ortoxicity of DaRT.

  • Patients must agree to use adequate contraception (vasectomy or barrier method ofbirth 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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Experimental: DaRT seeds
Phase:
Study Start date:
March 22, 2023
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Hadassah Ein Kerem

    Jerusalem,
    Israel

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.