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Procedure

MRgFUS vs. CTgRFA for Bone Tumors

Phase 3
Recruiting
Led By Matthew Bucknor, MD
Research Sponsored by Matthew Bucknor
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Targeted lesion deeper than 1 cm from skin and clearly visible by non-contrast MRI
Patients with medically uncontrolled pain from osteoid osteoma significantly interfering with daily activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial will compare two methods for treating osteoid osteomas, a type of painful, benign bone tumor. The first method uses MR-guided focused ultrasound (MRgFUS), while the other uses CT-guided radiofrequency ablation (CTgRFA). The goal is to see if MRgFUS is noninferior to CTgRFA in terms of pain reduction.

Who is the study for?
This trial is for men and women aged 8 or older with painful, benign bone tumors called osteoid osteomas. Participants must have a confirmed diagnosis, be able to undergo MRI exams and receive anesthesia, have not had previous treatments for the tumor, and suffer from significant pain despite medication.Check my eligibility
What is being tested?
The study compares MR-guided Focused Ultrasound (MRgFUS) with CT-guided Radiofrequency Ablation (CTgRFA) in treating osteoid osteomas. It aims to determine if MRgFUS is as effective as CTgRFA in reducing pain while potentially improving recovery time, patient experience, resource use, and side effects.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site post-procedure for both interventions. There could also be risks associated with sedation/anesthesia required during the procedure and specific complications related to each technique.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be seen on an MRI and is deeper than 1 cm from the skin.
Select...
I have severe pain from osteoid osteoma that affects my daily life.
Select...
I can safely have an MRI and handle anesthesia.
Select...
I can care for myself but may not be able to do active work.
Select...
The area where my bone cancer is can be reached by the ExAblate device.
Select...
I have not had any treatments for osteoid osteoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0)
Secondary outcome measures
Adverse events
Medication use
Patient preference
+3 more

Trial Design

2Treatment groups
Active Control
Group I: MRgFUSActive Control1 Intervention
Magnetic resonance-guided focused ultrasound ablation
Group II: CTgRFAActive Control1 Intervention
Computed tomography-guided radiofrequency ablation

Find a Location

Who is running the clinical trial?

Matthew BucknorLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Focused Ultrasound FoundationOTHER
15 Previous Clinical Trials
258 Total Patients Enrolled
Matthew Bucknor, MDPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

CTgRFA (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02923011 — Phase 3
Osteoma Research Study Groups: MRgFUS, CTgRFA
Osteoma Clinical Trial 2023: CTgRFA Highlights & Side Effects. Trial Name: NCT02923011 — Phase 3
CTgRFA (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02923011 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being signed up for this clinical trial?

"That is correct, the information available on clinicaltrials.gov affirms that this study is still looking for participants. This trial was originally posted on March 28th, 2017 and has since been updated on May 16th, 2022. In total, the research team needs 56 patients from 2 different hospitals or clinics."

Answered by AI

Is there a high risk associated with MRgFUS treatments?

"MRgFUS has received a 3 for safety because it is in Phase 3 testing. This means that not only does some data support efficacy, but multiple rounds of tests have shown MRgFUS to be safe."

Answered by AI

Are researchers still looking for volunteers for this experiment?

"The listing on clinicaltrials.gov affirms that this study is open for enrollment and actively recruiting patients. This trial was first posted on March 28th, 2017 and was last updated on May 16th, 2022. They are looking for 56 participants to enroll at two different medical sites."

Answered by AI

Who else is applying?

What site did they apply to?
UCSF Imaging Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
Matthew Bucknor 2017. "Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02923011.
~5 spots leftby Dec 2024
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