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 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors|
- Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: ExAblate transcranial system
MR Guided Focused Ultrasound
Device: ExAblate transcranial system
MRI-Guided Focused Ultrasound Feasibility Study for Brain
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:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147056
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Danielle Chamberlain 617-525-8596 email@example.com|
|Principal Investigator: Ferenc Jolesz, MD|
|United States, Washington|
|Swedish Medical Center||Recruiting|
|Seattle, Washington, United States, 98122|
|Contact: Colleen Ottinger 206-320-3070 Focusedultrasound@swedish.org|
|Contact: Mary Lessig 206-320-3070 Focusedultrasound@swedish.org|
|Principal Investigator: Charles Cobbs, MD|