5493W-13 A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasoun

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

Type of Study
Neuroscience - Brain Tumor
Short Description
The purpose of this study it to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system.  It is a non-randomized feasibility study that will enroll up to 10 subjects.  The subjects will be followed over a 3-month period with contrast MRI and clinical exams.
Status
Open
Principal Investigator
Stephen Monteith, MD
Eligibility Notes
  • Subjects with (newly diagnosed or recurrent) metastatic cancer for whom surgery, radiation, or radiosurgery has not been advised by the treating physician  
  • The targeted tumor tissue is located in the cerebral hemispheres, > 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.   
  • Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans. 
  • Karnofsky rating 70-100 and ASA scrore 1-2
  • At least 14 days passed since last brain surgery, or intracranial radiation therapy/radiosurgery
  • More than 3 metastatic tumors are exclusionary 
  • No TIA or Stroke in the last month
Contact Name
Focused Ultrasound Central Line
Phone
206-320-3070
Email
focusedultrasound@swedish.org