MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain lesions performed through intact human skull using the ExAblate 3000 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. The hypothesis of the study is to determine if FUS under MRI-guidance and MRI-based thermometry can be safely delivered through an intact human skull with a low risk of transient short-term adverse effects as evaluated during follow-up of up to 3 months and a pre-defined target volume inside the brain lesion can be accurately ablated, as shown on post-treatment MRI.
Recurrent Metastatic Cancer to the Brain
Device: ExAblate 3000
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Lesions|
- MRI Guilded Focused ultrasound feasibility study for brain tumors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Device: ExAblate 3000
Non-invasive focused ultrasound surgery has special appeal for use inside the skull, where it is desirable to destroy lesions deep in the brain without damage to the surrounding brain tissue or other structures.
The ExAblate systems are the result of an 8-year development by InSightec and GE Medical Systems. These systems combine a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T MRI scanner.
The ExAblate 2000 system is being used at Brigham and Women's (BWH) and in about a dozen other hospitals around the world for clinical trials in for the treatment of uterine fibroids, breast fibroadenoma, and breast carcinoma.