Bone MetastasesNCT00656305
ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain
A study testing ExAblate MRfFUS in people with Bone Metastases and Multiple Myeloma, run by InSightec at 14 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone Metastases, Multiple Myeloma
- What is being tested?
- ExAblate MRfFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Mar 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- And
- do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study.
- No radiation therapy to targeted (most painful) lesion in the past two weeks
- Bisphosphonate intake should remain stable throughout the study duration.
- Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States8 sites
University MRI & Diagnostic Imaging Centers
Boca Raton, Florida, 33431
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
University of California San Diego
La Jolla, California, 92093-0987
Weill Cornell Medical College
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Stanford University Medical Center
Stanford, California, 94305-5642
Moffitt Cancer Center
Tampa, Florida, 33612
Israel2 sites
Rambam medical Center -The Pain palliation unit
Haifa, 31096
Sheba Medical Center
Tel HaShomer, 52621
Russia2 sites
Rostov State Research Institute of Oncology
Rostov-on-Don, 344037
N. N. Petrov Institute of Oncology
Saint Petersburg, 197758
About this study
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
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
- Conditions
- Bone Metastases, Multiple Myeloma
- Being tested
- ExAblate MRfFUS, Sham
- Keywords
- Bone Cancer, Pain Palliation, Metastasis, Multiple Myeloma, Breast Cancer, Lung Cancer, Prostate Cancer, cancer related Pain, Tumors
- Medical subject headings
- Multiple Myeloma, Bone Neoplasms, Neoplasm Metastasis, Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Cancer Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MRfFUSDevice
Also called MRgFUS, FUS, Focused Ultrasound, MR guided Focused Ultrasound
MR guided focused ultrasound.
ShamDevice
sham comparator
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Treatment Arm | Experimental | Not described Receives: Device: ExAblate MRfFUS |
| ExAblate Sham Arm | Sham comparator | Not described Receives: Device: ExAblate MRfFUS; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post treatment
Secondary outcomes (2)
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)
Measured: 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.
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656305
- Sponsor's protocol ID
- BM004
- Status last verified
- Jan 2020
- First submitted
- 2 Apr 2008
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 32858582Hurwitz 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.
PubMed 24760791
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00656305
- Acronym / sponsor ID
- BM004
- Conditions
- Bone Metastases, Multiple Myeloma
- Keywords
- Bone Cancer, Pain Palliation, Metastasis, Multiple Myeloma, Breast Cancer, Lung Cancer, Prostate Cancer, cancer related Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ExAblate Treatment Arm | Experimental | Device: ExAblate MRfFUS |
| ExAblate Sham Arm | Sham comparator | Device: ExAblate MRfFUS, Device: Sham |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (32 listed)
- Patients who either
- OR
- More than 5 painful lesions, or more than 1 requiring immediate localized treatment
- Targeted (treated) tumor is in the skull
- Patients on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate MRfFUSAlso: MRgFUS, FUS, Focused Ultrasound, MR guided Focused UltrasoundMR guided focused ultrasound. | Device | ExAblate Sham Arm, ExAblate Treatment Arm |
| Shamsham comparator | Device | ExAblate Sham Arm |
Primary outcome
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.
2 secondary outcomes
Number of Participants With a Change in Medication Use
Time frame: 3 months post treatment
Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline
Time frame: 3 months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32858582Bitton 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.
- Derived from this study: PubMed 24760791Hurwitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate MRfFUS in people with Bone Metastases and Multiple Myeloma, run by InSightec at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Israel, Russia, Canada, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Responders (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.