Osteoid OsteomaPhase 3NCT02923011
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
A Phase 3 study testing MRgFUS and CTgRFA in people with Osteoid Osteoma, run by Matthew Bucknor at 3 sites in United States.
Trial summary
Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoid Osteoma
- What is being tested?
- MRgFUS and CTgRFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Mar 2017to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men and women ages ≥ 8 years old.
- Diagnosis of osteoid osteoma as confirmed when a musculoskeletal radiologist and orthopedic oncologist agree that a patient's imaging and clinical history are most compatible with the diagnosis of osteoid osteoma. A patient referred by a clinician other than orthopedic oncologist will require a clinic visit with an orthopedic oncologist for study inclusion.
- Patients must have medically uncontrolled pain from an osteoid osteoma, as defined by pain, which, in the view of the referring orthopedic oncologist significantly interferes with that patient's activities of daily living. Pain may be refractory to management with medications because of inadequate pain control, or because of side effects of the pain medication.
- If patients have an additional site of pain, it must be 2 points less severe and distinguishable from the pain at the osteoid osteoma site.
- Patients (or guardians/parents) who are able and willing to give consent (or assent where applicable) and able to attend all study visits.
- No prior interventional therapy for the osteoid osteoma.
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- Able to safely undergo MRI exam, tolerate being in an MRI scanner, and receive anesthesia/sedation for the treatment.
- Targeted bone/tumor interface is accessible to the ExAblate device and located in a rib, extremity (excluding intra-articular location), pelvis, shoulders (including clavicles), or the sternum.
- Targeted lesion must be deeper than 1 cm from the skin.
- Targeted lesion must be clearly visible by non-contrast MRI.
- Karnofsky Performance Status > 60.
Who cannot join
- Patients a) who need surgical stabilization of the affected bone (elevated fracture risk) or b) whose targeted tumor is at an impending fracture site, as determined by the referring orthopedic oncologist.
- Targeted tumor in the skull/spine.
- Targeted tumor is < 1 cm from a major nerve.
- Pregnancy.
- 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: patients on anti-arrhythmic drugs, unstable angina pectoris, documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic).
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- Severe hypertension (diastolic BP > 100 on medication)
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices.
- Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- Severe cerebrovascular disease.
- Known intolerance or allergy to medications used for sedation/anesthesia.
- Known intolerance or allergy to MR contrast agent (gadolinium chelates).
- Patients unable to communicate with the investigator and staff.
- Patients with persistent pain undistinguishable from the target lesion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maya Aslam contact
United States3 sites, 3 recruiting
- Recruiting
Stanford Medical Center
Palo Alto, California, 94305
Krithika Rupnarayan, krupnara@stanford.edu
Pejman Ghanouni, MD, PhD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Christin Tiegs-Heiden, MD, TiegsHeiden.Christin@mayo.edu
Christin Tiegs-Heiden, MD
- Recruiting
UCSF Imaging Center
San Francisco, California, 94107
Maya Aslam, maya.aslam@ucsf.edu
Matthew Bucknor, MD
About this study
Official title: Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas
Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.
- Conditions
- Osteoid Osteoma
- Being tested
- MRgFUS, CTgRFA
- Medical subject headings
- Osteoma, Osteoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgFUSDevice
Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
CTgRFADevice
Computed tomography-guided radiofrequency ablation of osteoid osteoma
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS | Active comparator | Magnetic resonance-guided focused ultrasound ablation Receives: Device: MRgFUS |
| CTgRFA | Active comparator | Computed tomography-guided radiofrequency ablation Receives: Device: CTgRFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0)
1 month after treatment, worst VAS score over the last 24 hours will be assessed
Measured: 1 month
Secondary outcomes (6)
Procedure time
On the day of the treatment, the procedure time will be recorded
Measured: Treatment day
Patient preference
2 weeks after treatment, patient preference surveys will be assessed
Measured: 2 weeks
Patient quality of life
1 month after treatment, patient quality of life surveys will be assessed
Measured: 1 month
Medication use
Self reported medication use for 5 days before, five days after, and 1 month after the treatment
Measured: 5 days before, five days after, 1 month after
Adverse events
All adverse events occurring within the first month will be recorded at 1 month following the procedure
Measured: 1 month
Worst VAS
Worst VAS over the last 24 hours will be assessed for each of the first 5 days following the treatment and then at 1 week, 2 weeks, 3 weeks, 1 month, 6 months, and 12 months following the treatment
Measured: First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start28 Mar 2017
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Bucknor
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Responsible party
- Sponsor-investigator, Matthew Bucknor, University of California, San Francisco
- Investigators
- Matthew Bucknor, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923011
- Sponsor's protocol ID
- FUS513
- Status last verified
- Feb 2025
- First submitted
- 30 Sep 2016
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas
- ClinicalTrials.gov ID
- NCT02923011
- Acronym / sponsor ID
- FUS513
- Conditions
- Osteoid Osteoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Matthew BucknorUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Oct 2016 (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.
Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRgFUS | Active comparator | Device: MRgFUSMagnetic resonance-guided focused ultrasound ablation |
| CTgRFA | Active comparator | Device: CTgRFAComputed tomography-guided radiofrequency ablation |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women ages ≥ 8 years old.
- Diagnosis of osteoid osteoma as confirmed when a musculoskeletal radiologist and orthopedic oncologist agree that a patient's imaging and clinical history are most compatible with the diagnosis of osteoid osteoma. A patient referred by a clinician other than orthopedic oncologist will require a clinic visit with an orthopedic oncologist for study inclusion.
- Patients must have medically uncontrolled pain from an osteoid osteoma, as defined by pain, which, in the view of the referring orthopedic oncologist significantly interferes with that patient's activities of daily living. Pain may be refractory to management with medications because of inadequate pain control, or because of side effects of the pain medication.
- If patients have an additional site of pain, it must be 2 points less severe and distinguishable from the pain at the osteoid osteoma site.
- Patients (or guardians/parents) who are able and willing to give consent (or assent where applicable) and able to attend all study visits.
Key exclusion criteria (14 listed)
- Patients a) who need surgical stabilization of the affected bone (elevated fracture risk) or b) whose targeted tumor is at an impending fracture site, as determined by the referring orthopedic oncologist.
- Targeted tumor in the skull/spine.
- Targeted tumor is < 1 cm from a major nerve.
- Pregnancy.
- Patients with an acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study.
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 |
|---|---|---|
| MRgFUSMagnetic resonance-guided focused ultrasound ablation of osteoid osteoma | Device | MRgFUS |
| CTgRFAComputed tomography-guided radiofrequency ablation of osteoid osteoma | Device | CTgRFA |
Primary outcome
Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0)
Time frame: 1 month
1 month after treatment, worst VAS score over the last 24 hours will be assessed
6 secondary outcomes
Procedure time
Time frame: Treatment day
Patient preference
Time frame: 2 weeks
Patient quality of life
Time frame: 1 month
Medication use
Time frame: 5 days before, five days after, 1 month after
Adverse events
Time frame: 1 month
Worst VAS
Time frame: First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoid Osteoma
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MR-HIFU Treatment of Painful Osteoid Osteoma
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.
Maya Aslam contact
Matthew Bucknor, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRgFUS and CTgRFA in people with Osteoid Osteoma, run by Matthew Bucknor at 3 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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Aslam (maya.aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0) (time frame: 1 month). 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 19 Feb 2025.