Comparing two treatments for painful bone tumors

Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas

This study is testing whether a new ultrasound treatment can help relieve pain from benign bone tumors as well as a standard heat-based treatment for patients aged 8 and older.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 3 sites (Palo Alto, California and 2 other locations)
• Trial ID: NCT02923011 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) and CT-guided Radiofrequency Ablation (CTgRFA) in treating osteoid osteomas, which are benign but painful bone tumors. The aim is to determine if MRgFUS is as effective as CTgRFA in reducing pain and improving patient outcomes, while also assessing factors such as post-procedural pain and resource utilization. The study will involve patients aged 8 years and older who have been diagnosed with osteoid osteoma and are experiencing uncontrolled pain. Data collected will help clinicians make informed decisions regarding treatment options for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 8 years and older with a confirmed diagnosis of osteoid osteoma and uncontrolled pain that significantly interferes with daily activities.

Not a fit: Patients with osteoid osteomas who do not experience significant pain or have pain that is well-managed with medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from osteoid osteomas, potentially leading to better pain management and improved quality of life.

How similar studies have performed: Other studies have shown promising results with focused ultrasound techniques for various conditions, suggesting potential success for this novel approach in treating osteoid osteomas.

Eligibility criteria

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.

Where this trial is running

Palo Alto, California and 2 other locations

• Stanford Medical Center — Palo Alto, California, United States (Recruiting)
• UCSF Imaging Center — San Francisco, California, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Matthew Bucknor, MD — University of California, San Francisco
• Study coordinator: Maya Aslam

Conditions Osteoid Osteoma