Focused Ultrasound Therapy
The FDA has approved Profound Medical’s Sonalleve device for the treatment of patients with Osteoid Osteoma. For more information on treatment site locations, please see Profound Medical’s website.
Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with osteoid osteoma. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling osteoid osteoma to be treated without surgery.
Advantages
The primary options for treatment of osteoid osteoma include pain medications, but some cases require invasive surgery.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.
Clinical Trials
A study has opened at the University of California in San Francisco (UCSF) and Stanford University, which is comparing MR-guided focused ultrasound treatment for osteoid osteoma to radiofrequency ablation.
A clinical trial at Children’s National in Washington D.C. is treating patients with painful osteoid osteoma and has completed their enrollment. .
A clinical trial in France is treating patients with bone metastatic lesions or with osteoid osteoma.
A registry, funded in part by the Foundation, has begun and will enroll more patients at additional sites worldwide. For more information, contact Simal Goman at 416-813-6456.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
See here for a list of treatment sites
See here for a list of clinical trials sites
See here for a list of laboratory research sites
Find a Treatment Site
Search for a treatment center or clinical trial near you.
Regulatory Approval and Reimbursement
The Profound Medical Sonalleve is FDA approved for treatment of osteoid osteoma in the US. Chongqing Haifu Medical Technology is approved for osteoid osteoma in Europe, Russia and China. The Insightec ExAblate Neuro is approved for treating this condition in Europe.
To date, focused ultrasound is not widely reimbursed by medical insurers for treatment of osteoid osteoma.
Notable Papers
Erber B, Geßl A, Reidler P, Dürr HR, Klein A, Seidensticker M, Wildgruber M, Ricke J, Sabel B. Impact of reactive sclerosis on outcome of MR-HIFU for osteoid osteomas. Eur J Radiol. 2025 Feb;183:111902. doi: 10.1016/j.ejrad.2024.111902. Epub 2024 Dec 26. PMID: 39753004
Ciatawi K, Dusak IWS, Wiratnaya IGE. High-intensity focused ultrasound-a needleless management for osteoid osteoma: a systematic review. Musculoskelet Surg. 2023 Dec 27. doi: 10.1007/s12306-023-00801-1. PMID: 38150115
Hu R, He P, Tian X, Guan H. Efficacy and safety of magnetic resonance-guided focused ultrasound for the treatment of osteoid osteoma: A systematic review and meta-analysis. Eur J Radiol. 2023 Jul 22;166:111006. doi: 10.1016/j.ejrad.2023.111006. PMID: 37523874
Acanfora C, Grassi E, Giacobbe G, Ferrante M, Granata V, Barile A, Cappabianca S. Post-Procedural Follow-Up of the Interventional Radiology’s Management of Osteoid Osteomas and Osteoblastomas. J Clin Med. 2022 Apr 2;11(7):1987. doi: 10.3390/jcm11071987.
Parmeggiani A, Martella C, Ceccarelli L, Miceli M, Spinnato P, Facchini G. Osteoid osteoma: which is the best mininvasive treatment option? Eur J Orthop Surg Traumatol. 2021 Apr 11. doi: 10.1007/s00590-021-02946-w.
Arrigoni F, Spiliopoulos S, de Cataldo C, Reppas L, Palumbo P, Mazioti A, Bruno F, Zugaro L, Papakonstantinou O, Barile A, Kelekis A, Masciocchi C, Filippiadis D. A bicentric propensity score matching study comparing percutaneous computed tomography-guided radiofrequency Ablation to Magnetic Resonance-guided Focused Ultrasounds for the treatment of osteoid osteoma. J Vasc Interv Radiol. 2021 Mar 25:S1051-0443(21)00932-5. doi: 10.1016/j.jvir.2021.03.528.
Arrigoni F, Bruno F, Gianneramo C, Palumbo P, Zugaro L, Zoccali C, Barile A, Masciocchi C. Evolution of the imaging features of osteoid osteoma treated with RFA or MRgFUS during a long-term follow-up: a pictorial review with clinical correlations. Radiol Med. 2020 Feb 10. doi: 10.1007/s11547-020-01134-w.
Arrigoni F, Napoli A, Bazzocchi A, Zugaro L, Scipione R, Bruno F, Palumbo P, Anzidei M, Mercatelli D, Gravina GL, Zoccali C, Ghanouni P, Barile A, Catalano C, Masciocchi C. Magnetic-resonance-guided focused ultrasound treatment of non-spinal osteoid osteoma in children: multicentre experience. Pediatr Radiol. 2019 May 25. doi: 10.1007/s00247-019-04426-0. [Epub ahead of print] PMID: 31129699
Click here for additional references from PubMed.