for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion




Official Title

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System




  1. Pain relief
  2. Preservation and restoration of function
  3. Local tumor control
  4. Skeletal stabilization




Bone Metastases bone cancer pain palliation metastasis breast cancer lung cancer prostate cancer cancer related pain tumors Neoplasm Metastasis ExAblate 2100


You can join if…

Open to people ages 18 years and up

  1. Men and women age 18 and older
  3. Patients who are suffering from symptoms of bone metastases
  4. One to 3 painful lesions.
  6. Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated:

o If patient has pain from additional sites that are not planned for treatment, 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(s) to be treated.

  1. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication
  2. Targeted tumors (most painful) size up to 8 cm in diameter
  3. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin.
  4. . Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
  5. . Able to communicate sensations during the ExAblate MRgFUS treatment
  6. . At least 2 weeks since chemotherapy
  7. . No radiation therapy to targeted (most painful) tumors in the past two weeks

You CAN'T join if...

  1. Patients who either
  2. Need surgical stabilization of the affected weight bearing bony structure (>7 fracture risk score, see Section 6.9) OR
  3. Targeted tumor is at an impending fracture site of the weigh bearing bone (>7 on fracture risk score, see Section 6.9).


o Patients with surgical stabilization of tumor site with metallic hardware

  1. More than 3 painful lesions or more than 2 requiring immediate localized treatment
  2. The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
  3. Targeted tumor is in the skull
  4. Patients on dialysis
  5. Patients with life expectancy < 6-Months
  7. Patients with unstable cardiac status including:
  8. Unstable angina pectoris on medication
  9. Patients with documented myocardial infarction within six months of protocol entry
  10. Congestive heart failure requiring medication (other than diuretic)
  11. Patients on anti-arrhythmic drugs
  12. Severe hypertension (diastolic BP > 100 on medication)
  14. . Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  16. . KPS Score < 60 (See "Definitions" below)
  17. . Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
  18. . Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time.)
  19. . Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels or bladder.
  21. . Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks
  22. . Patients unable to communicate with the investigator and staff.
  23. . Patients with persistent undistinguishable pain (pain source unidentifiable)
  24. . Targeted (most painful) tumors size > 8 cm in diameter
  25. . Targeted (most painful) tumors:
  26. NOT visible by non-contrast MRI, OR
  27. NOT accessible to ExAblate device


  • University of California San Francisco
    San Francisco California 94107 United States
  • Stanford University Medical Center
    Stanford California 94305 United States


in progress, not accepting new patients
Start Date
Completion Date
Sponsor's web page
Study Type
Last Updated