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RECRUITING
NCT05781555
NA

Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors

Sponsor: Alpha Tau Medical LTD.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-03-22

Completion Date

2027-04

Last Updated

2026-04-06

Healthy Volunteers

No

Conditions

Interventions

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 (1)

Hadassah Ein Kerem

Jerusalem, Israel