A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

Inclusion Criteria:

* Men and women age 18 and older
* Patients who are able and willing to give consent and able to attend all study visits
* Patients who are suffering from symptoms of bone metastases or multiple myeloma bone lesions:
* Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician
* those for whom their treating physician would not prescribe radiation or additional radiation treatments
* patients who refuse additional radiation therapy.
* Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication
* Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
* Targeted bone/tumor interface (most painful lesion) size up to 55 cm2 in surface area
* Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
* Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
* Able to communicate sensations during the ExAblate treatment
* Patients on ongoing chemotherapy regimen at the time of eligibility:

  1. with same chemotherapy regime (as documented from patient medical dossier), And
  2. Worst pain NRS still ≥ 4 And
  3. do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study.

Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.

* No radiation therapy to targeted (most painful) lesion in the past two weeks Bisphosphonate intake should remain stable throughout the study duration.
* Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.
* Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site to be treated).

Exclusion Criteria:

* Patients who either
* Need surgical stabilization of the affected bony structure (\>7 fracture risk score, see Section 7.4) OR
* Targeted tumor is at an impending fracture site (\>7 on fracture risk score, see Section 7.4).

OR

* Patients with surgical stabilization of tumor site with metallic hardware
* More than 5 painful lesions, or more than 1 requiring immediate localized treatment
* Targeted (treated) tumor is in the skull
* Patients on dialysis
* Patients with life expectancy \< 3-Months
* Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
* 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
* Severe hypertension (diastolic BP \> 100 on medication)
* Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
* Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
* Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
* KPS Score \< 60 (See "Definitions" below)
* Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
* Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
* Target (treated) tumor is less then 1cm from nerve bundles, bowels or bladder.
* Are participating or have participated in another clinical trial in the last 30 days
* Patients initiating a new chemotherapy regime for pain purposes only, or radiation (for the targeted most painful lesion) within the last 2 weeks Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
* Patients unable to communicate with the investigator and staff.
* Patients with persistent undistinguishable pain (pain source unidentifiable of the targeted lesion)
* Patient whose bone-lesion interface is \< 10-mm from the skin
* Targeted (most painful) tumor NOT visible by non-contrast MRI,
* Targeted (most painful) tumor Not accessible to ExAblate
* The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.