Bone MetastasesNCT02616016
MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children
A study testing MRI Guided High Intensity Focused Ultrasound in people with Bone Metastases and Pain, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No serious adverse effects are expected to result from this treatment. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Bone Metastases, Pain
- What is being tested?
- MRI Guided High Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to 2 May 2024
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- able to give informed consent
- weight <140 kg (requirement to fit safely on top of the HIFU table and inside MRI
- any radiologic evidence of bone metastases from any solid tumor (neuroblastoma, osteosarcoma, soft tissue sarcoma, or any other solid tumor metastases).
- pain specifically at the site of interest (target lesion)
- pain score for target lesion >/ = 4 (indicating at least moderate pain) on an age-appropriate 0-10 point scale
- Target lesion in uncomplicated (ie no fracture / spinal cord compression /cauda equine syndrome/ soft tissue component)
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- Available 3D MRI image of the target lesion (or be able to obtain one in a clinically feasible amount of time as part of the baseline investigational stage.)
- Proposed MR-HIFU treatment date >/= 2 weeks from most recent treatment of target tumour or systems chemotherapy
- Proposed MR-HIFU treatment date >/= 1 week after administration of steroids for pain flare
Who cannot join
- Unable to characterize pain specifically at the site of interest (target lesion).
- Pregnant / nursing females
- Target lesion is complicated (ie pressure of one fracture /spinal cord compression/cauda equine syndrome/soft tissue component)
- Target lesion < 1cm from nerve bundles/ bladder/bowel
- Target lesion in contact with hollow viscera
- Target lesion located in skull, spine (excluding sacrum which is allowed) or sternum.
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- scar along proposed HIFU beam path.
- Orthopaedic implant along proposed HIIFU beam path or at site of target lesion.
- Active infection.
- Contradiction to general anesthesia or or gadolinium MRI contrast agent.
- Requirement for general anaesthesia for non -HIFU related MRI scans.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases in Children - A Pilot Study
The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No serious adverse effects are expected to result from this treatment.
Read the detailed description
The objective of this study is to determine if MR-guided high intensity focused ultrasound (MR-HIFU) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. This technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. Safety of the technique will be assessed through evaluating non-targeted heating using MRI-based temperature mapping, and inspecting patients post-treatment for skin burns. or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 3 months following treatment.
- Conditions
- Bone Metastases, Pain
- Being tested
- MRI Guided High Intensity Focused Ultrasound
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Guided High Intensity Focused UltrasoundDevice
Target treatment of bone metastases using High Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| MRI guided High Intensity Focused Ultrasound Treatment | Other | Intervention Group The interventional radiologist will locate the target tissue and mark the volume to be treated using MRI images.
The operator starts the treatment and monitors the progress of the treatment with MR thermal and dose maps to ensure adherence to treatment plan.
An individual treatment sonication will last approximately 30 seconds. Receives: Device: MRI Guided High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity scores from baseline as measured on pain diaries.
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days following treatment.
Measured: 2, 7, 14, 30 and 90 days following treatment
Secondary outcomes (1)
Improved patient quality of life after MR-HIFU using a quality of life questionnaire.
Using age appropriate quality of life questionnaire that involves interviewing patient and/or parent/guardian before and 2, 7, 14, 30 and 90 days post treatment.
Measured: 2, 7, 14, 30 and 90 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startApr 2014
- Primary completion2 May 2024
- Study completion2 May 2024
Why it stopped: We had challenges related to participant recruitment due to inclusion/exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, James Drake, The Hospital for Sick Children
- Investigators
- James M Drake, FRCSC,FACS, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616016
- Sponsor's protocol ID
- 1000040604
- Status last verified
- May 2024
- First submitted
- 18 Nov 2015
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. 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 in Children - A Pilot Study
- ClinicalTrials.gov ID
- NCT02616016
- Acronym / sponsor ID
- 1000040604
- Conditions
- Bone Metastases, Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We had challenges related to participant recruitment due to inclusion/exclusion criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Apr 2014
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 26 Nov 2015 (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 Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No serious adverse effects are expected to result from this treatment.
Detailed description
The objective of this study is to determine if MR-guided high intensity focused ultrasound (MR-HIFU) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. This technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. Safety of the technique will be assessed through evaluating non-targeted heating using MRI-based temperature mapping, and inspecting patients post-treatment for skin burns. or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 3 months following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI guided High Intensity Focused Ultrasound Treatment | Other | Device: MRI Guided High Intensity Focused UltrasoundIntervention Group The interventional radiologist will locate the target tissue and mark the volume to be treated using MRI images. The operator starts the treatment and monitors the progress of the treatment with MR thermal and dose maps to ensure adherence to treatment plan. An individual treatment sonication will last approximately 30 seconds. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- able to give informed consent
- weight <140 kg (requirement to fit safely on top of the HIFU table and inside MRI
- any radiologic evidence of bone metastases from any solid tumor (neuroblastoma, osteosarcoma, soft tissue sarcoma, or any other solid tumor metastases).
- pain specifically at the site of interest (target lesion)
- pain score for target lesion >/ = 4 (indicating at least moderate pain) on an age-appropriate 0-10 point scale
Key exclusion criteria (11 listed)
- Unable to characterize pain specifically at the site of interest (target lesion).
- Pregnant / nursing females
- Target lesion is complicated (ie pressure of one fracture /spinal cord compression/cauda equine syndrome/soft tissue component)
- Target lesion < 1cm from nerve bundles/ bladder/bowel
- Target lesion in contact with hollow viscera
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 |
|---|---|---|
| MRI Guided High Intensity Focused UltrasoundTarget treatment of bone metastases using High Intensity Focused Ultrasound | Device | MRI guided High Intensity Focused Ultrasound Treatment |
Primary outcome
Change in pain intensity scores from baseline as measured on pain diaries.
Time frame: 2, 7, 14, 30 and 90 days following treatment
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days following treatment.
1 secondary outcome
Improved patient quality of life after MR-HIFU using a quality of life questionnaire.
Time frame: 2, 7, 14, 30 and 90 days post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
James M Drake, FRCSC,FACS principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Guided High Intensity Focused Ultrasound in people with Bone Metastases and Pain, run by The Hospital for Sick Children at 1 site in Canada.
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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in pain intensity scores from baseline as measured on pain diaries. (time frame: 2, 7, 14, 30 and 90 days following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.