ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain
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
1 other identifier
interventional
147
5 countries
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 2, 2008
CompletedFirst Posted
Study publicly available on registry
April 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
November 14, 2018
CompletedFebruary 5, 2020
January 1, 2020
4.5 years
April 2, 2008
August 13, 2018
January 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months post treatment
Secondary Outcomes (2)
Number of Participants With a Change in Medication Use
3 months post treatment
Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline
3 months post treatment
Study Arms (2)
ExAblate Treatment Arm
EXPERIMENTALExAblate Sham Arm
SHAM COMPARATORInterventions
MR guided focused ultrasound.
Eligibility Criteria
You may qualify if:
- Men and women age 18 and older
- Patients who are able and willing to give consent and able to attend all study visits
- 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,
- Patients who refuse other accepted available treatments such as surgery or narcotics for pain alleviation.
- Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication
- 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)
- Targeted tumor (treated) size up to 55 cm2 in surface area
- Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
- Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
- Able to communicate sensations during the ExAblate treatment
- 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
- +6 more criteria
You may not qualify if:
- 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
- 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)
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (14)
University of California San Diego
La Jolla, California, 92093-0987, United States
Stanford University Medical Center
Stanford, California, 94305-5642, United States
University MRI & Diagnostic Imaging Centers
Boca Raton, Florida, 33431, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Rambam medical Center -The Pain palliation unit
Haifa, 31096, Israel
Sheba Medical Center
Tel Litwinsky, 52621, Israel
University of Rome "La Sapienza"
Rome, 00161, Italy
Rostov State Research Institute of Oncology
Rostov-on-Don, 344037, Russia
N. N. Petrov Institute of Oncology
Saint Petersburg, 197758, Russia
Related Publications (2)
Bitton RR, Rosenberg J, LeBlang S, Napoli A, Meyer J, Butts Pauly K, Hurwitz M, Ghanouni P. MRI-Guided Focused Ultrasound of Osseous Metastases: Treatment Parameters Associated With Successful Pain Reduction. Invest Radiol. 2021 Mar 1;56(3):141-146. doi: 10.1097/RLI.0000000000000721.
PMID: 32858582DERIVEDHurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5):dju082. doi: 10.1093/jnci/dju082.
PMID: 24760791DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nadir Alikacem
- Organization
- InSightec
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2008
First Posted
April 11, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
February 5, 2020
Results First Posted
November 14, 2018
Record last verified: 2020-01