Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

NCT02923011 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: FUS513
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief 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, 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

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (6)

• Procedure time

  Treatment day

• Patient preference

  2 weeks

• Patient quality of life

  1 month

• Medication use

  5 days before, five days after, 1 month after

• Adverse events

  1 month

Study Arms (2)

MRgFUS

ACTIVE COMPARATOR

Magnetic resonance-guided focused ultrasound ablation

Device: MRgFUS

CTgRFA

ACTIVE COMPARATOR

Computed tomography-guided radiofrequency ablation

Device: CTgRFA

Interventions

MRgFUS DEVICE

Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma

MRgFUS

CTgRFA DEVICE

Computed tomography-guided radiofrequency ablation of osteoid osteoma

CTgRFA

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages ≥ 8 years old.
• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Matthew Bucknor: lead
• Focused Ultrasound Foundation: collaborator

Study Sites (3)

Stanford Medical Center

Palo Alto, California, 94305, United States

RECRUITING

UCSF Imaging Center

San Francisco, California, 94107, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Osteoma, Osteoid

Condition Hierarchy (Ancestors)

Osteoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Matthew Bucknor, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

maya.aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Residence

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 4, 2016
• Study Start: March 28, 2017
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)