Bone MetastasisNCT01833806

A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

A study testing ExAblate MRgFUS in people with Bone Metastasis, run by InSightec at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bone Metastasis
What is being tested?: ExAblate MRgFUS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 9 sitesUnited States
Study dates: Sep 2013to 14 Jan 2022
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 years and older
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:
Patients 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
patients who refuse additional radiation therapy.

Show all 20Show fewer

Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication
Targeted bone/tumor interface 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 bone/tumor interface (most painful lesion) 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 at the time of eligibility:
with same chemotherapy regime (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.
Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
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 7.4) OR
Targeted tumor is at an impending fracture site (>7 on fracture risk score, see Section 7.4).
OR
Patients with surgical stabilization of tumor site with metallic hardware
More than 5 painful lesions, or more than 1 requiring immediate localized treatment

Show all 31Show fewer

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, 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 for pain purposes only, or radiation (for the targeted most painful lesion) within the last 2 weeks Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
Patients unable to communicate with the investigator and staff.
Patients with persistent undistinguishable pain (pain source unidentifiable of the targeted lesion)
Patient whose bone-lesion interface is < 10-mm from the skin
Targeted (most painful) 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

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

University of Virginia
Charlottesville, Virginia, 22908
City of Hope
Duarte, California, 91010
MD Anderson
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90024
Weill Cornell Medical Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94107
Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.

Read the detailed description

As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines.

For this study, participating sites will use the ExAblate device for the administration of the ExAblate treatment. This study will be performed on either 1.5T or 3T MR scanners.

For this study, a total of 70 patients meeting the approved commercial guidelines will be enrolled and treated with the ExAblate system at from 7 to 10 sites. The proportion of responders is expected to be at least 30% greater than the proportion of subjects experiencing pain progression (i.e., 60% vs. 30%). Additionally, at the 3 month visit, an analysis of both the safety and efficacy profiles will be compared to the original PMA pivotal study group.

Conditions: Bone Metastasis
Being tested: ExAblate MRgFUS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExAblate MRgFUSDevice
Also called Magnetic Resonance guided Focused Ultrasound Surgery
Focused Ultrasound Ablation

Study groups in NCT01833806
Study group	Role	What they receive
ExAblate Test Arm	Experimental	Focused Ultrasound Surgery delivered by ExAblate MRgFUS Receives: Device: ExAblate MRgFUS

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Responders
The statistical hypothesis is that the proportion of responders will be significantly greater than the proportion of subjects experiencing pain progression (worsened pain or increased pain medications usage). Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), subjects were rated as a Responder or as having Pain Progression. 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. Pain Progression was increased pain of two (2) or more points.
Measured: Three months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201314 Jan 2022

First posted17 Apr 2013 (estimated)
Study startSep 2013
Primary completion14 Jan 2022
Study completion14 Jan 2022

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.
Other trials for Bone MetastasisStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01833806
Sponsor's protocol ID: BM018
Other IDs: P110039/S2
Status last verified: Apr 2023
First submitted: 12 Apr 2013
Last updated: 7 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bone Metastasis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
ClinicalTrials.gov ID: NCT01833806
Acronym / sponsor ID: BM018
Conditions: Bone Metastasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: InSightecIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: 14 Jan 2022 (actual)
Study completion: 14 Jan 2022 (actual)
First posted: 17 Apr 2013 (estimated)
Results: Posted 7 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.

Detailed description

As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines.

For this study, participating sites will use the ExAblate device for the administration of the ExAblate treatment. This study will be performed on either 1.5T or 3T MR scanners.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ExAblate Test Arm	Experimental	Device: ExAblate MRgFUSFocused Ultrasound Surgery delivered by ExAblate MRgFUS

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 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:
Patients 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

Key exclusion criteria (31 listed)

Patients who either
Need surgical stabilization of the affected bony structure (>7 fracture risk score, see Section 7.4) OR
Targeted tumor is at an impending fracture site (>7 on fracture risk score, see Section 7.4).
OR
Patients with surgical stabilization of tumor site with metallic hardware

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 MRgFUSAlso: Magnetic Resonance guided Focused Ultrasound SurgeryFocused Ultrasound Ablation	Device	ExAblate Test Arm

Primary outcome

Proportion of Responders
Time frame: Three months post treatment
The statistical hypothesis is that the proportion of responders will be significantly greater than the proportion of subjects experiencing pain progression (worsened pain or increased pain medications usage). Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), subjects were rated as a Responder or as having Pain Progression. 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. Pain Progression was increased pain of two (2) or more points.

Results and safety

Results posted to the registry on 7 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ExAblate Test Arm	32	23

Primary outcome: Proportion of Responders

Time frame: Three months post treatment. Count of participants. Unit: Participants

Measure	ExAblate Test Arm n = 31
Responders	18
Pain Progression	5
No Change	8

ExAblate Test Arm: Proportion Difference: 0.78 (95% CI 0.58 to 0.98), p = 0.01, Binomial

Population analysed: The analysis was based on 31 treated subjects that completed at least one follow up visit; 23 out of 31 subjects were either Responders or had Pain Progression. Eight subjects reported no change in pain.

Adverse events

Time frame: Adverse events were collected for 3 months following intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ExAblate Test Arm	1 of 32 (3.1%)	6 of 32 (18.8%)	5 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bone Metastasis

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Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
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Not yet recruitingPhase 2
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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.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ExAblate MRgFUS in people with Bone Metastasis, run by InSightec at 9 sites in United States.

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 20 inclusion and 31 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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. 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 7 Apr 2023). 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?

Proportion of Responders (time frame: Three 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 NCT01833806.

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 7 Apr 2023.