A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors.
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.
January 01, 1900
Neuroscience - Brain Tumor
Stephen Monteith, MD
- 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
Focused Ultrasound Central Line