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:
• with same chemotherapy regime (as documented from patient medical dossier), And
• Worst pain NRS still ≥ 4 And
• 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 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 visib