SIR 2024
Pediatric Interventions
Ryan Tang, BA
Medical Student
University of South Florida, Morsani College of Medicine
Financial relationships: Full list of relationships is listed on the CME information page.
Pavel Yarmolenko, PhD, BS, BA
Assistant Professor
The Sheikh Zayed Institute for Pediatric Surgical Innovation
Disclosure information not submitted.
Emily Leibold, BS, BA
Clinical Research Coordinator
Children's National Hospital
Disclosure information not submitted.
Matthew Oetgen, MD
Orthopedic Surgeon
Childrens National Medical Center
Disclosure information not submitted.
Robert Henshaw, MD
Orthopedic Oncologist
Children's National Medical Center
Disclosure information not submitted.
Pamela Hinds, PhD, RN
Chair of Nursing Research
Children's National Medical Center
Disclosure information not submitted.
Aerang Kim, MD, PhD
Oncologist
Childrens National Medical Center
Disclosure information not submitted.
Karun V. Sharma, MD, PhD, FSIR
Director of Interventional Radiology
Children's National Medical Center
Disclosure information not submitted.
Osteoid osteoma (OO) is a benign but painful bone tumor that most commonly occurs in the cortex of long bones of children and adolescents. Magnetic resonance imaging-guided high intensity focused ultrasound (MR-HIFU) allows precise, image-guided and completely non-invasive ablation without ionizing radiation and has been shown by several groups, including ours, to be a good treatment alternative to RFA. Herein we report interim results of an ongoing pivotal trial (NCT04658771).
Materials and Methods:
Primary objective of this study is to determine treatment efficacy of MR-HIFU ablation of painful OO in children and young adults. Sixteen patients with symptomatic OO have been enrolled. Fifteen (11M, 4F, 11±4 years) have undergone MR-HIFU ablation on an IRB-approved clinical trial. Eleven have completed one year follow up. Pain relief was assessed using Visual Analog Scale (VAS) pain score and pain/medication logs. Quality of life (QOL) was assessed using patient reported outcome measurement tools. Patients were followed at 1 day, 1 week, 1,6, and 12 months.
Results: Eleven patients underwent technically successful MR-HIFU ablation without any significant adverse events. The median worst pre-treatment VAS score was 8 (with NSAIDs) and at 1 year post-treatment was 0, which is significant (Wilcoxon, p< 0.0001). Median total SDS scores decreased from 18 to 12 at one year, demonstrating significant improvement in patients’ QOL (Wilcoxon, p=0.0166). The Pediatric Pain Interference Short Form (PROMIS®) median total standardized t scores decreased by 21.7 at one year, demonstrating decreased impact of pain on various aspects of the patients’ life following treatment (Wilcoxon, p=0.0001). The overall patient and parent PedsQL™ scores showed a significant improvement in several aspects of QOL (Wilcoxon, p< 0.0001). Specifically, the PedsQL™ sleep score showed a significant improvement in sleep quality amongst all patients (Wilcoxon, p=0.0005). Ten patients underwent follow up contrast-enhanced MRI at 1 year. OO nidus perfusion was reduced or eliminated in 8 of the patients. Soft tissue edema resolved in 9 out of 10 patients and bone marrow edema was reduced or resolved in 8 out of 10 patients.
Conclusion: MR-HIFU has emerged as a non-invasive treatment option for symptomatic OO that is safe and effective. Interim analysis of results from the ongoing pivotal trial add to existing data demonstrating durable pain relief and improved QOL.