Osteoid OsteomaNCT02618369
MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults
A study testing MR-Guided High Intensity Focused Ultrasound in people with Osteoid Osteoma and Benign Bone Tumor, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. No serious adverse effects are expected to result from this treatment. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Osteoid Osteoma, Benign Bone Tumor, Pain
- What is being tested?
- MR-Guided High Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Oct 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 5-40 years.
- Able to give informed consent and have parent or guardian give informed consent if applicable.
- Weight <140 kg (requirement to fit safely on top of the HIFU table and inside the MRI).
- Definitive radiographic \& clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy).
- Pain specifically at the site of interest target lesion.
- Pain score for target lesion >/= 4 (indicating at least moderate pain) or an age-appropriate pain scale.
- Target lesion is uncomplicated (i.e. no fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
- MR-HIFU treatment date >/= 2 weeks from most recent surgical treatment of lesion.
Who cannot join
- Unable to characterize pain specifically at the site of interest (target lesion).
- Pregnant/nursing females.
- Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
- Target lesion < 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth).
- Target lesion located in skull, spine (excluding sacrum, which is allowed) or sternum.
- Scar along proposed HIFU beam path.
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- Orthopaedic implant along proposed HIFU beam path or at site of target tissue.
- Serious cardiovascular, neurological, renal or haematological chronic disease.
- Active infection.
- Contraindication to general anaesthetic or gadolinium MRI contrast agent.
- Requirement for general anesthesia for non-HIFU related MRI's.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults
The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. 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 safe and effective technique for alleviating the pain associated with osteoid osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs). This technique meant to be an alternative to the standard-of-care, radiofrequency and laser-based percutaneous ablation. 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 6 months following treatment.
- Conditions
- Osteoid Osteoma, Benign Bone Tumor, Pain
- Being tested
- MR-Guided High Intensity Focused Ultrasound
- Keywords
- High Intensity Focused Ultrasound
- Medical subject headings
- Osteoma, Osteoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Guided High Intensity Focused UltrasoundDevice
Target treatment of bone lesion using High Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU treatment | Other | The interventional radiologist will locate the target lesion 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. Receives: Device: MR-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 related to the site treated target lesion.
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.
Measured: 2, 7, 14, 30 and 90 days following treatment.
Secondary outcomes (1)
Reduction in in pain medication usage (NSAIDS, Opioids).
As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after treatment.
Measured: 2, 7, 14, 30 and 90 days following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoid OsteomaStudies 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
- 10 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
- NCT02618369
- Sponsor's protocol ID
- 1000040583
- Status last verified
- May 2024
- First submitted
- 23 Nov 2015
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults
- ClinicalTrials.gov ID
- NCT02618369
- Acronym / sponsor ID
- 1000040583
- Conditions
- Osteoid Osteoma, Benign Bone Tumor, Pain
- Keywords
- High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Apr 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Dec 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 HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. 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 safe and effective technique for alleviating the pain associated with osteoid osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs). This technique meant to be an alternative to the standard-of-care, radiofrequency and laser-based percutaneous ablation. 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 6 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 |
|---|---|---|
| MR-HIFU treatment | Other | Device: MR-Guided High Intensity Focused UltrasoundThe interventional radiologist will locate the target lesion 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. |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 5-40 years.
- Able to give informed consent and have parent or guardian give informed consent if applicable.
- Weight <140 kg (requirement to fit safely on top of the HIFU table and inside the MRI).
- Definitive radiographic \& clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy).
- Pain specifically at the site of interest target lesion.
Key exclusion criteria (11 listed)
- Unable to characterize pain specifically at the site of interest (target lesion).
- Pregnant/nursing females.
- Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
- Target lesion < 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth).
- Target lesion located in skull, spine (excluding sacrum, which is allowed) or sternum.
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-Guided High Intensity Focused UltrasoundTarget treatment of bone lesion using High Intensity Focused Ultrasound | Device | MR-HIFU treatment |
Primary outcome
Change in pain intensity scores from baseline related to the site treated target lesion.
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 after treatment.
1 secondary outcome
Reduction in in pain medication usage (NSAIDS, Opioids).
Time frame: 2, 7, 14, 30 and 90 days following treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
Related trials for Osteoid Osteoma
Active, not recruitingPhase 2
MR-HIFU Treatment of Painful Osteoid Osteoma
Osteoid Osteoma
RecruitingPhase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
Osteoid Osteoma
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 MR-Guided High Intensity Focused Ultrasound in people with Osteoid Osteoma and Benign Bone Tumor, 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 8 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 related to the site treated target lesion. (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.