Actively Recruiting
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
Led by Matthew Bucknor · Updated on 2025-02-19
56
Participants Needed
3
Research Sites
430 weeks
Total Duration
On this page
Sponsors
M
Matthew Bucknor
Lead Sponsor
F
Focused Ultrasound Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women ages 63 8 years old
- Diagnosis of osteoid osteoma confirmed by musculoskeletal radiologist and orthopedic oncologist
- Medically uncontrolled pain from osteoid osteoma significantly interfering with daily activities
- If additional pain sites exist, they must be at least 2 points less severe and distinguishable from osteoid osteoma pain
- Ability and willingness to give consent or assent and attend all study visits
- No prior interventional therapy for the osteoid osteoma
- Ability to safely undergo MRI exam, tolerate MRI scanner, and receive anesthesia or sedation
- Targeted bone/tumor interface accessible to ExAblate device and located in rib, extremity (excluding intra-articular), pelvis, shoulders (including clavicles), or sternum
- Targeted lesion deeper than 1 cm from the skin
- Targeted lesion clearly visible by non-contrast MRI
- Karnofsky Performance Status greater than 60
You will not qualify if you...
- Need for surgical stabilization of affected bone or tumor at impending fracture site
- Targeted tumor located in skull or spine
- Targeted tumor less than 1 cm from a major nerve
- Pregnancy
- Acute medical conditions expected to interfere with study completion
- Unstable cardiac status including use of anti-arrhythmic drugs, unstable angina, recent myocardial infarction, or congestive heart failure
- Severe hypertension (diastolic BP > 100 on medication)
- Standard contraindications for MRI such as non-compatible metallic implants
- Active infection or severe uncontrolled hematological, neurological, or other diseases
- Severe cerebrovascular disease
- Known intolerance or allergy to sedation/anesthesia medications
- Known intolerance or allergy to MRI contrast agents (gadolinium chelates)
- Inability to communicate with study staff
- Persistent pain indistinguishable from target lesion pain
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Stanford Medical Center
Palo Alto, California, United States, 94305
Actively Recruiting
2
UCSF Imaging Center
San Francisco, California, United States, 94107
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
M
Maya Aslam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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