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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781555
Other study ID # CTP- ALL-00
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2023
Est. completion date April 2025

Study information

Verified date May 2024
Source Alpha Tau Medical LTD.
Contact Liron Dimnik
Phone +972237377000
Email LironD@alphatau.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Israel Hadassah Ein Kerem Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To assess the tumor response to DaRT treatment 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
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