MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 ]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 2017|
|Estimated Primary Completion Date:||December 2017 (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||Completed|
|Boston, Massachusetts, United States, 02115|
|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|