Bone MetastasisNCT01586273
Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases
A study testing MR-HIFU treatment for pain palliation of bone metastases in people with Bone Metastasis, run by Philips Healthcare at 3 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases. 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?
- MR-HIFU treatment for pain palliation of bone metastases
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2012to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with age ≥ 18 years
- Patient capable of giving informed consent and able to attend study visits
- Weight < 140kg
- Radiologic evidence of bone metastases from any solid tumor
- Diagnosis of dominant painful bone metastasis (Numerical Representative Scale (NRS) pain score ≥4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is contra-indicated or refused by patient.
- Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date
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- Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
- Patient has 1-3 painful lesions, and only the most painful lesion will be treated
- Intended Target Volume accessible for MR-HIFU procedure
- Target lesion maximum dimension ≤ 8cm
- Intended target volume visible by non-contrast MRI
- Distance between target and skin ≥ 1cm
- Patient is able to communicate sensation during MR-HIFU treatment
- MR-HIFU treatment date ≥ 4 weeks from last local treatment of the target lesion
Who cannot join
- Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
- Communication barrier present
- Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
- Unable to tolerate required stationary position during treatment
- Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50% of bone diameter)
- Pregnant woman
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- Pain related to target lesion is predominantly due to fracture or impending fracture
- Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
- Target < 3cm from bladder / bowel / nerve along the beam path and < 1cm in the plane orthogonal to the beam
- Target in contact with hollow viscera
- Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum
- Scar along proposed HIFU beam path
- Internal or external fixation device along the proposed HIFU beam path or at the target
- MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
- MRI contrast agent contraindicated (e.g. previous anaphylaxis or Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m2)
- Sedation contraindicated
- Previous surgery or minimally invasive treatment at targeted site
- Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Royal Marsden Hospital / Institute of Cancer Research
Sutton, Surrey, SM2 5PT
About this study
Official title: Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases.
Read the detailed description
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the target field and to perform real-time thermal mapping at and around the target.
The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores in patients with painful bone metastases and in reducing their pain medication usage.
- Conditions
- Bone Metastasis
- Being tested
- MR-HIFU treatment for pain palliation of bone metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-HIFU treatment for pain palliation of bone metastasesDevice
Also called Philips Sonalleve MR-HIFU Bone Pain Palliative Therapy
A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU treatment | Experimental | Subjects undergo a MR-HIFU treatment for pain palliation of bone metastases on their most painful metastasis. Receives: Device: MR-HIFU treatment for pain palliation of bone metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response to therapy
Pain is measured using the Brief Pain Inventory (BPI) questionnaire. Patients are categorized into:
- Complete response (CR): Pain score 0 without analgesic increase
- Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase
- Pain Progression (PP): Pain increase of 2 or more with stable analgesic use; or increase of 25% or more in analgesic use, with pain score stable or 1 point above baseline
- No response corresponds to all other cases
Patients with PR or CR at 30 days are considered responders to therapy.
Measured: 30 days after treatment
Secondary outcomes (4)
Total number of Adverse Events
Total number of complications and adverse events, including the number of unintended lesions that occur as a result of treatment with MR-HIFU.
Measured: within the first 90 days within treatment
Quality of Life (as measured by questionnaire)
Quality of Life will be measured at the given time points using a dedicated questionnaire for patients in palliative care: the European Organisation on Research and Treatment of Cancer (EORTC) C15-PAL questionnaire.
Measured: at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment
Subgroup analysis: pain response in radiation naïve patients
Assessment of positive response on pain (as determined by the Primary Outcome Measure) will be documented separately for radiation naïve patients and radiation failure patients, and a comparison between the two sub-groups will be performed.
Measured: 30 days after treatment
Temporal evolution of pain response during the first 30 days after treatment
Patients are given a diary to complete during the first 30 days after treatment, which documents their daily pain level on a 0-10 scale and their pain medication usage.
Measured: during the first 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice A van den Bosch, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586273
- Sponsor's protocol ID
- 906273
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Catane R, Beck A, Inbar Y, Rabin T, Shabshin N, Hengst S, Pfeffer RM, Hanannel A, Dogadkin O, Liberman B, Kopelman D. MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. Ann Oncol. 2007 Jan;18(1):163-167. doi: 10.1093/annonc/mdl335. Epub 2006 Oct 9.
PubMed 17030549Gianfelice D, Gupta C, Kucharczyk W, Bret P, Havill D, Clemons M. Palliative treatment of painful bone metastases with MR imaging--guided focused ultrasound. Radiology. 2008 Oct;249(1):355-63. doi: 10.1148/radiol.2491071523. Epub 2008 Aug 11.
PubMed 18695209Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicenter study. Ann Surg Oncol. 2009 Jan;16(1):140-6. doi: 10.1245/s10434-008-0011-2. Epub 2008 Nov 11.
PubMed 19002530Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
PubMed 21489705Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Groenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB; EORTC Quality of Life Group. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer. 2006 Jan;42(1):55-64. doi: 10.1016/j.ejca.2005.06.022. Epub 2005 Sep 12.
PubMed 16162404Chow E, Hird A, Velikova G, Johnson C, Dewolf L, Bezjak A, Wu J, Shafiq J, Sezer O, Kardamakis D, van der Linden Y, Ma B, Castro M, Arnalot PF, Ahmedzai S, Clemons M, Hoskin P, Yee A, Brundage M, Bottomley A; EORTC Quality of Life Group. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with bone metastases: the EORTC QLQ-BM22. Eur J Cancer. 2009 May;45(7):1146-1152. doi: 10.1016/j.ejca.2008.11.013. Epub 2008 Dec 25.
PubMed 19097882
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
- ClinicalTrials.gov ID
- NCT01586273
- Acronym / sponsor ID
- 906273
- Conditions
- Bone Metastasis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases.
Detailed description
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the target field and to perform real-time thermal mapping at and around the target.
The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores in patients with painful bone metastases and in reducing their pain medication usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-HIFU treatment | Experimental | Device: MR-HIFU treatment for pain palliation of bone metastasesSubjects undergo a MR-HIFU treatment for pain palliation of bone metastases on their most painful metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women with age ≥ 18 years
- Patient capable of giving informed consent and able to attend study visits
- Weight < 140kg
- Radiologic evidence of bone metastases from any solid tumor
- Diagnosis of dominant painful bone metastasis (Numerical Representative Scale (NRS) pain score ≥4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is contra-indicated or refused by patient.
Key exclusion criteria (18 listed)
- Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
- Communication barrier present
- Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
- Unable to tolerate required stationary position during treatment
- Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50% of bone diameter)
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 |
|---|---|---|
| MR-HIFU treatment for pain palliation of bone metastasesAlso: Philips Sonalleve MR-HIFU Bone Pain Palliative TherapyA treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound. | Device | MR-HIFU treatment |
Primary outcome
Pain response to therapy
Time frame: 30 days after treatment
Pain is measured using the Brief Pain Inventory (BPI) questionnaire. Patients are categorized into: * Complete response (CR): Pain score 0 without analgesic increase * Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase * Pain Progression (PP): Pain increase of 2 or more with stable analgesic use; or increase of 25% or more in analgesic use, with pain score stable or 1 point above baseline * No response corresponds to all other cases Patients with PR or CR at 30 days are considered responders to therapy.
4 secondary outcomes
Total number of Adverse Events
Time frame: within the first 90 days within treatment
Quality of Life (as measured by questionnaire)
Time frame: at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment
Subgroup analysis: pain response in radiation naïve patients
Time frame: 30 days after treatment
Temporal evolution of pain response during the first 30 days after treatment
Time frame: during the first 30 days after treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 17030549Catane R, Beck A, Inbar Y, Rabin T, Shabshin N, Hengst S, Pfeffer RM, Hanannel A, Dogadkin O, Liberman B, Kopelman D. MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. Ann Oncol. 2007 Jan;18(1):163-167. doi: 10.1093/annonc/mdl335. Epub 2006 Oct 9.
- Background: PubMed 18695209Gianfelice D, Gupta C, Kucharczyk W, Bret P, Havill D, Clemons M. Palliative treatment of painful bone metastases with MR imaging--guided focused ultrasound. Radiology. 2008 Oct;249(1):355-63. doi: 10.1148/radiol.2491071523. Epub 2008 Aug 11.
- Background: PubMed 19002530Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicenter study. Ann Surg Oncol. 2009 Jan;16(1):140-6. doi: 10.1245/s10434-008-0011-2. Epub 2008 Nov 11.
- Background: PubMed 21489705Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 16162404Groenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB; EORTC Quality of Life Group. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer. 2006 Jan;42(1):55-64. doi: 10.1016/j.ejca.2005.06.022. Epub 2005 Sep 12.
- Background: PubMed 19097882Chow E, Hird A, Velikova G, Johnson C, Dewolf L, Bezjak A, Wu J, Shafiq J, Sezer O, Kardamakis D, van der Linden Y, Ma B, Castro M, Arnalot PF, Ahmedzai S, Clemons M, Hoskin P, Yee A, Brundage M, Bottomley A; EORTC Quality of Life Group. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with bone metastases: the EORTC QLQ-BM22. Eur J Cancer. 2009 May;45(7):1146-1152. doi: 10.1016/j.ejca.2008.11.013. Epub 2008 Dec 25.
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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.
Maurice A van den Bosch, MD, PhD principal investigator
UMC Utrecht
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-HIFU treatment for pain palliation of bone metastases in people with Bone Metastasis, run by Philips Healthcare at 3 sites in 3 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 14 inclusion and 18 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: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, South Korea, United Kingdom. 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?
The study was stopped early. Results are not available in the source record.
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?
Pain response to therapy (time frame: 30 days after 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 NCT01586273, which also lists 7 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 4 Apr 2017.