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

Not Applicable

Completed

Conditions: Bone Metastases
Multiple Myeloma

Interventions: Device: ExAblate MRfFUS
Device: Sham

Registration Number: NCT00656305

Lead Sponsor: InSightec

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 147

Inclusion Criteria

Not provided

Exclusion Criteria

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
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 < 3-Months
patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
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
Severe hypertension (diastolic BP > 100 on medication)
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >250 pounds), 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, or radiation (for the targeted most painful lesion) within the last 2 weeks
Patients unable to communicate with the investigator and staff.
Patients with persistent undistinguishable pain (pain source unidentifiable)
Targeted (treated) tumor surface area >= 55 cm2
Patient whose bone-lesion interface is < 10-mm from the skin
Targeted (treated) tumor NOT visible by non-contrast MRI,
Targeted (most painful) tumor Not accessible to ExAblate
The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ExAblate Sham Arm	ExAblate MRfFUS	-
ExAblate Sham Arm	Sham	-
ExAblate Treatment Arm	ExAblate MRfFUS	-

Primary Outcome Measures

Name	Time	Method
Number of Responders	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

Name	Time	Method
Number of Participants With a Change in Medication Use	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)
Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline	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.

Trial Locations

Locations (14): University MRI & Diagnostic Imaging Centers
🇺🇸
Boca Raton, Florida, United States
Weill Cornell Medical College
🇺🇸
New York, New York, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Sheba Medical Center
🇮🇱
Tel Hashomer, Israel
University of California San Diego
🇺🇸
La Jolla, California, United States
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
Rambam medical Center -The Pain palliation unit
🇮🇱
Haifa, Israel
University of Rome "La Sapienza"
🇮🇹
Rome, Italy
Rostov State Research Institute of Oncology
🇷🇺
Rostov on Don, Russian Federation
N. N. Petrov Institute of Oncology
🇷🇺
St. Petersburg, Russian Federation