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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656305
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : November 14, 2018
Last Update Posted : February 5, 2020
Information provided by (Responsible Party):

Brief Summary:
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy

Condition or disease Intervention/treatment Phase
Bone Metastases Multiple Myeloma Device: ExAblate MRfFUS Device: Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy
Study Start Date : March 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: ExAblate Treatment Arm Device: ExAblate MRfFUS
MR guided focused ultrasound.
Other Names:
  • MRgFUS
  • FUS
  • Focused Ultrasound
  • MR guided Focused Ultrasound

Sham Comparator: ExAblate Sham Arm Device: ExAblate MRfFUS
MR guided focused ultrasound.
Other Names:
  • MRgFUS
  • FUS
  • Focused Ultrasound
  • MR guided Focused Ultrasound

Device: Sham
sham comparator

Primary Outcome Measures :
  1. Number of Responders [ Time Frame: 3 months post treatment ]
    Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.

Secondary Outcome Measures :
  1. Number of Participants With a Change in Medication Use [ Time Frame: 3 months post treatment ]
    Medication Use change reported from baseline until of study. Medication use is quantified by "morphine equivalent usage" (measured separately from Responder/Non-responder definition for the primary endpoint)

  2. Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline [ Time Frame: 3 months post treatment ]
    The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents 'does not interfere' and 10 indicates 'completely interferes'. Responses to the 7 items are averaged to form the pain interference scale score. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 or multiple myeloma bone lesions and are radiation failure patients:

    Radiation failure candidates are those 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, and those patients who refuse additional radiation therapy,

  4. Patients who refuse other accepted available treatments such as surgery or narcotics for pain alleviation.
  5. Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication
  6. 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)
  7. Targeted tumor (treated) size up to 55 cm2 in surface area
  8. Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
  9. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
  10. Able to communicate sensations during the ExAblate treatment
  11. Patients on ongoing chemotherapy regimen for at least 1 month at the time of eligibility:

    - with same chemotherapy regimen (as documented from patient medical dossier),


    - Worst pain NRS still >= 4


    - do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study.

  12. No radiation therapy to targeted (most painful) lesion in the past two weeks
  13. Bisphosphonate intake should remain stable throughout the study duration.
  14. Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.
  15. 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:

  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).


    - 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656305

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United States, California
University of California San Diego
La Jolla, California, United States, 92093-0987
Stanford University Medical Center
Stanford, California, United States, 94305-5642
United States, Florida
University MRI & Diagnostic Imaging Centers
Boca Raton, Florida, United States, 33431
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Rambam medical Center -The Pain palliation unit
Haifa, Israel, 31096
Sheba Medical Center
Tel Hashomer, Israel, 52621
University of Rome "La Sapienza"
Rome, Italy, 00161
Russian Federation
Rostov State Research Institute of Oncology
Rostov on Don, Russian Federation, 344037
N. N. Petrov Institute of Oncology
St. Petersburg, Russian Federation, 197758
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: InSightec Identifier: NCT00656305    
Other Study ID Numbers: BM004
First Posted: April 11, 2008    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: February 5, 2020
Last Verified: January 2020
Keywords provided by InSightec:
Bone Cancer
Pain Palliation
Multiple Myeloma
Breast Cancer
Lung Cancer
Prostate Cancer
cancer related Pain
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes