Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoid Osteoma
• Intervention / Treatment: Device: MRgFUS; Device: CTgRFA

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Maya Aslam; Email: maya.aslam@ucsf.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford Medical Center
      • Contact: Krithika Rupnarayan; Email: krupnara@stanford.edu
      • Principal Investigator: Pejman Ghanouni, MD, PhD
    • San Francisco, California, United States, 94107
      • Recruiting
      • UCSF Imaging Center
      • Contact: Maya Aslam; Email: maya.aslam@ucsf.edu
      • Principal Investigator: Matthew Bucknor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men and women ages ≥ 8 years old.
2. 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.
3. 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.
4. 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.
5. Patients (or guardians/parents) who are able and willing to give consent (or assent where applicable) and able to attend all study visits.
6. No prior interventional therapy for the osteoid osteoma.
7. Able to safely undergo MRI exam, tolerate being in an MRI scanner, and receive anesthesia/sedation for the treatment.
8. 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.
9. Targeted lesion must be deeper than 1 cm from the skin.
10. Targeted lesion must be clearly visible by non-contrast MRI.
11. Karnofsky Performance Status > 60.

Exclusion Criteria:

1. 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.
2. Targeted tumor in the skull/spine.
3. Targeted tumor is < 1 cm from a major nerve.
4. Pregnancy.
5. Patients with an acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study.
6. 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).
7. Severe hypertension (diastolic BP > 100 on medication)
8. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices.
9. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
10. Severe cerebrovascular disease.
11. Known intolerance or allergy to medications used for sedation/anesthesia.
12. Known intolerance or allergy to MR contrast agent (gadolinium chelates).
13. Patients unable to communicate with the investigator and staff.
14. Patients with persistent pain undistinguishable from the target lesion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MRgFUS; Magnetic resonance-guided focused ultrasound ablation	Device: MRgFUS; Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
Active Comparator: CTgRFA; Computed tomography-guided radiofrequency ablation	Device: CTgRFA; Computed tomography-guided radiofrequency ablation of osteoid osteoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	On the day of the treatment, the procedure time will be recorded	Treatment day
Patient preference	2 weeks after treatment, patient preference surveys will be assessed	2 weeks
Patient quality of life	1 month after treatment, patient quality of life surveys will be assessed	1 month
Medication use	Self reported medication use for 5 days before, five days after, and 1 month after the treatment	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	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	First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Matthew Bucknor
• Collaborators: Focused Ultrasound Foundation
• Investigators: Principal Investigator: Matthew Bucknor, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimated): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Osteoma; Osteoma, Osteoid
• Other Study ID Numbers: FUS513

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes