ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain

Not Recruiting

Trial ID: NCT00981578


A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.

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

Stanford Investigator(s)

David Hovsepian, MD
David Hovsepian, MD

Clinical Professor, Radiology

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor and Professor of Medicine (Oncology)

Pejman Ghanouni, MD, PhD
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)


Inclusion Criteria:

   1. Men and women age 18 and older

   2. Patients who are able and willing to give consent and able to attend all study visits

   3. Patients who are suffering from symptoms of bone metastases

   4. One to 3 painful lesions.

   5. Targeted tumor(s) 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)

   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.

   7. 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

   8. Targeted tumors (most painful) size up to 8 cm in diameter

   9. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is
   deeper than 1cm from the skin.

10. Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate
   MRgFUS device accessible

11. Able to communicate sensations during the ExAblate MRgFUS treatment

12. At least 2 weeks since chemotherapy

13. No radiation therapy to targeted (most painful) tumors in the past two weeks

Exclusion Criteria:

   1. Patients who either

      - Need surgical stabilization of the affected weight bearing bony structure (>7
      fracture risk score, see Section 6.9) OR

      - 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

   2. More than 3 painful lesions or more than 2 requiring immediate localized treatment

   3. The targeted tumor(s) is (are) less than 2 points more painful compared to other
   non-targeted painful lesions on the site specific NRS.

   4. Targeted tumor is in the skull

   5. Patients on dialysis

   6. Patients with life expectancy < 6-Months

   7. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to
   hinder them from completing this study.

   8. Patients with unstable cardiac status including:

      - Unstable angina pectoris on medication

      - Patients with documented myocardial infarction within six months of protocol

      - Congestive heart failure requiring medication (other than diuretic)

      - Patients on anti-arrhythmic drugs

   9. Severe hypertension (diastolic BP > 100 on medication)

10. Patients with standard contraindications for MR imaging such as non-MRI compatible
   implanted metallic devices including cardiac pacemakers, size limitations, etc.

11. Patients with an active infection or severe hematological, neurological, or other
   uncontrolled disease.

12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
   Magnevist) including advanced kidney disease

13. KPS Score < 60 (See "Definitions" below)

14. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

15. 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.)

16. Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels
   or bladder.

17. Are participating or have participated in another clinical trial for the palliation of
   their targeted bone metastasis tumors in the last 30 days

18. Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within
   the last two weeks

19. Patients unable to communicate with the investigator and staff.

20. Patients with persistent undistinguishable pain (pain source unidentifiable)

21. Targeted (most painful) tumors size > 8 cm in diameter

22. Targeted (most painful) tumors:

      - NOT visible by non-contrast MRI, OR

      - NOT accessible to ExAblate device


device: ExAblate 2100

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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