NCT00147056

MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system. We will collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its clinical efficacy.

Detailed description

In this non-randomized feasibility study, FUS under MRI-guidance and thermometry will be given through intact human skull to brain tumor in up to ten (10) subjects. These subjects will be followed over a 3-month period with contrast MRI and clinical exams. The objectives are: 1. To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment, and during the follow-up period of 3 months. 2. To evaluate the effect of thermal ablation in the target tumor with contrast MR imaging to identify viable tumor, and non-viable thermally ablated tissue.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
DEVICE	ExAblate transcranial system	MRI-Guided Focused Ultrasound Feasibility Study for Brain

Timeline

• Start date: 2012-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2005-09-07
• Last updated: 2025-05-01

Locations

2 sites across 1 country: United States