MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors (NCT00147056) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
United States10 participantsStarted 2012-08
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Men or women.
✓. Age between 18 and 70 years, inclusive.
✓. Able and willing to give informed consent.
✓. 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.
✓. Size of the targeted portion of the tumor (i.e. prescribed Region Of Treatment) is less than 2.5 cm in diameter or 8 cm3 in volume. The non-targeted tumor tissue may exceed the targeted volume.
✓. Karnofsky rating 70-100 (See Appendix A).
Exclusion criteria
✕. The subject presents with:
✕. Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins
✕. TIA or stroke in the last 1 month
✕. Insulin-dependent diabetes mellitus
✕
What they're measuring
1
Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors