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RECRUITING
NCT05829291
NA

Alpha Radiation Emitters Device for the Treatment of Liver Metastases (DaRT)

Sponsor: Alpha Tau Medical LTD.

View on ClinicalTrials.gov

Summary

This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases. The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade\[1\] and to evaluate the radiological response of liver metastases using the RECIST criteria.

Official title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-10-01

Completion Date

2026-02

Last Updated

2024-05-10

Healthy Volunteers

No

Interventions

DEVICE

Diffusing Alpha Radiation Emitters Therapy (DaRT)

Alpha DaRT Applicators (the Alpha Needle Applicator, the Alpha Flex Applicator, and the Alpha Plant Applicator) and radioactive sources named Alpha DaRT Seeds - Ra-224 coated onto stainless steel tubes inserted into the tumor. Collectively, the Alpha DaRT Applicators and Seeds are referred to as the "Alpha DaRT Device".

Locations (1)

e McGill University Health Centre (MUHC)

Montreal, Quebec, Canada