MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00147056|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2005
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Device: ExAblate transcranial system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: ExAblate transcranial system
MR Guided Focused Ultrasound
Device: ExAblate transcranial system
MRI-Guided Focused Ultrasound Feasibility Study for Brain
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147056
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98122|