ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

Exclusion Criteria

• •1. Patients who either
• •* Need surgical stabilization of the affected bony structure (\>7 fracture risk score, see Section 7.3) OR
• •* Targeted tumor is at an impending fracture site (\>7 on fracture risk score, see Section 7.3).
• •OR
• •\- Patients with surgical stabilization of tumor site with metallic hardware
• •2. More than 5 painful lesions, or more than 1 requiring immediate localized treatment
• •3. Targeted (treated) tumor is in the skull
• •4. Patients on dialysis
• •5. Patients with life expectancy \< 3-Months
• •6. patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
• •7. Patients with unstable cardiac status including:
• •* Unstable angina pectoris on medication
• •* Patients with documented myocardial infarction within six months of protocol entry
• •* Congestive heart failure requiring medication (other than diuretic)
• •* Patients on anti-arrhythmic drugs
• •8. Severe hypertension (diastolic BP \> 100 on medication)
• •9. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight \>250 pounds), etc.
• •10. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
• •11. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
• •12. KPS Score \< 60 (See "Definitions" below)
• •13. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
• •14. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
• •15. Target (treated) tumor is less then 1cm from nerve bundles, bowels or bladder.
• •16. Are participating or have participated in another clinical trial in the last 30 days
• •17. Patients initiating a new chemotherapy regime, or radiation (for the targeted most painful lesion) within the last 2 weeks
• •18. Patients unable to communicate with the investigator and staff.
• •19. Patients with persistent undistinguishable pain (pain source unidentifiable)
• •20. Targeted (treated) tumor surface area \>= 55 cm2
• •21. Patient whose bone-lesion interface is \< 10-mm from the skin
• •22. Targeted (treated) tumor NOT visible by non-contrast MRI,
• •23. Targeted (most painful) tumor Not accessible to ExAblate
• •24. The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.