A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using MRI-Guided Focused Ultrasound in the treatment of Her2-positive breast cancer brain metastases

Project Name: A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using MRI-Guided Focused Ultrasound in the treatment of Her2-positive breast cancer brain metastases
Status: Active
Primary Site: Sunnybrook Health Sciences Centre
Sponsor Organization: Focused Ultrasound Foundation
Funded Date: Oct 31, 2019
Funding Program: Brain Program
Funding Period: Oct 31, 2019 - Oct 30, 2021
Amount Awarded: $234,163.00

Abstract

This study is a prospective, single-arm, non-randomized study to evaluate the safety of BBB disruption using MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of trastuzumab in brain metastasis and the adjacent brain using the ExAblate® Neuro System. Data will be collected in up to 10 patients to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy. During the treatment process (and prior to treatment day) on Day 1, the patient will receive a loading dose of trastuzumab in the chemotherapy suite. The patient will then return for treatment on Day 8. A trastuzumab infusion will be administered over 30 minutes. The delivery will be completed 30-60 minutes prior to the ultrasound. Actual treatment involves a 2 minute burst sonication will be initiated at the same time as a bolus injection of Definity® ultrasound contrast. The follow-up visits are scheduled at 1 week, 4 and 12 weeks after the treatment. Safety will be evaluated via clinical and neurological assessments and MR imaging with contrast during the treatment, and by follow-up MRI and clinical visits.

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