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

Sponsor

Alpha Tau Medical LTD. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05781555

Collaborator

(none)

100

Enrollment

Arm

22.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Tumor	Device: Experimental: DaRT seeds	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DaRT seeds Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	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.

Arm

Intervention/Treatment

Experimental: DaRT seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

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.

Outcome Measures

Primary Outcome Measures

To assess the frequency, severity and causality of acute adverse events. [From Day 0 (DaRT insertion )]
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.

Secondary Outcome Measures

To assess the tumor response to DaRT treatment [3 months after DaRT seed insertion]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.