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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
147
MR guided focused ultrasound.
sham comparator
University of California San Diego
La Jolla, California, United States
Stanford University Medical Center
Stanford, California, United States
University MRI & Diagnostic Imaging Centers
Number of Responders
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.
Time frame: 3 months post treatment
Number of Participants With a Change in Medication Use
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)
Time frame: 3 months post treatment
Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline
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.
Time frame: 3 months post treatment
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Boca Raton, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Toronto General Hospital
Toronto, Ontario, Canada
Rambam medical Center -The Pain palliation unit
Haifa, Israel
...and 4 more locations