ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Metastatic Bone Tumors for the Palliation of Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00656305
First received: April 2, 2008
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Bone Metastases
Multiple Myeloma
Device: ExAblate 2000
Device: Sham
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Improvement in Pain Scores [ Time Frame: Within 3 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in pain medications [ Time Frame: Within 3 months of treatment ] [ Designated as safety issue: No ]
  • Adverse device effects [ Time Frame: Within 3 months of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 147
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ExAblate Treatment Test Arm
Device: ExAblate 2000
MR guided focused ultrasound.
Other Names:
  • MRgFUS
  • FUS
  • Focused Ultrasound
  • MR guided Focused Ultrasound
Sham Comparator: 2
ExAblate Sham Control Arm
Device: ExAblate 2000
MR guided focused ultrasound.
Other Names:
  • MRgFUS
  • FUS
  • Focused Ultrasound
  • MR guided Focused Ultrasound
Device: Sham
sham comparator

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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),

    And

    - Worst pain NRS still >= 4

    And

    - 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).

    OR

    - 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656305

Locations
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
Israel
Rambam medical Center -The Pain palliation unit
Haifa, Israel, 31096
Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
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
InSightec
  More Information

Additional Information:
No publications provided by InSightec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00656305     History of Changes
Other Study ID Numbers: BM004
Study First Received: April 2, 2008
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
Bone Cancer
Pain Palliation
Metastasis
Multiple Myeloma
Breast Cancer
Lung Cancer
Prostate Cancer
cancer related Pain
Tumors

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014