Focused Ultrasound Therapy
Focused ultrasound is an early-stage, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with painful metastatic cancer to the bone. 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) of the pain-producing nerves around the cancer metastases without surgery, resulting in a significant reduction in pain.
The primary options for treatment of painful bone metastases include radiation and medications. In some cases surgery is considered.
For certain patients, focused ultrasound could provide a noninvasive, radiation-free alternative to conventional therapy with less risk of complications and lower cost. it is a low-morbidity treatment that allows for a quick return to normal life (usually the next day). A single therapy session can provide rapid and durable resolution of bone metastasis pain, and focused ultrasound pain relief does not have the adverse side effects of pain medications. It can also be repeated, if necessary
Regulatory Approval and Reimbursement
The following geographical regions have one or more focused ultrasound devices approved to treat painful bone metastases: USA (FDA), Europe (CE Mark), Korea (KFDA), Asia, Canada, Israel, India, Latin America and Russia.
Treatments are reimbursed in Italy and Germany. Most major health insurers in the US also cover focused ultrasound for bone metastases. In other countries, coverage may be available on a case-by-case or site basis.
For a full list of known bone metastases clinical trials, please see here.
Baal JD, Chen WC, Baal U, Wagle S, Baal JH, Link TM, Bucknor MD. Efficacy and safety of magnetic resonance-guided focused ultrasound for the treatment of painful bone metastases: a systematic review and meta-analysis. Skeletal Radiol. 2021 May 21. doi: 10.1007/s00256-021-03822-8.
Wang WJ, Lee HL, Jeng SC, Chiou JF, Huang Y. Real-Time Magnetic Resonance Guided Focused Ultrasound for Painful Bone Metastases. J Vis Exp. 2021 Mar 5;(169). doi: 10.3791/60615.
Lin X, Chen W, Wei F. Technique Success, Technique Efficacy and Complications of HIFU Ablation for Palliation of Pain in Patients With Bone Lesions: A Meta-Analysis of 28 Feasibility Studies. Ultrasound Med Biol. 2021 May;47(5):1182-1191. doi: 10.1016/j.ultrasmedbio.2021.01.018. Epub 2021 Feb 11.
Bartels MMTJ, Verpalen IM, Ferrer CJ, Slotman DJ, Phernambucq ECJ, Verhoeff JJC, Eppinga WSC, Braat MNGJA, van den Hoed RD, van 't Veer-Ten Kate M, de Boer E, Naber HR, Nijholt IM, Bartels LW, Bos C, Moonen CTW, Boomsma MF, Verkooijen HM. Combining radiotherapy and focused ultrasound for pain palliation of cancer induced bone pain; a stage I/IIa study according to the IDEAL framework. Clin Transl Radiat Oncol. 2021 Jan 15;27:57-63. doi: 10.1016/j.ctro.2021.01.005. eCollection 2021 Mar.
Bucknor MD, Chan FP, Matuoka JY, Curl PK, Kahn JG. Cost-effectiveness analysis of magnetic resonance-guided focused ultrasound ablation for palliation of refractory painful bone metastases. Int J Technol Assess Health Care. 2020 Dec 3:1-7. doi: 10.1017/S0266462320001907.
Bitton RR, Rosenberg J, LeBlang S, Napoli A, Meyer J, Butts Pauly K, Hurwitz M, Ghanouni P. MRI-Guided Focused Ultrasound of Osseous Metastases: Treatment Parameters Associated With Successful Pain Reduction. Invest Radiol. 2020 Aug 26. doi: 10.1097/RLI.0000000000000721.
Drost L, Hynynen K, Huang Y, Lucht B, Wong E, Czarnota G, Yee C, Wan BA, Ganesh V, Chow E, David E. Ultrasound-Guided Focused Ultrasound Treatment for Painful Bone Metastases: A Pilot Study. Ultrasound Med Biol. 2020 Mar 4. pii: S0301-5629(20)30058-2. doi: 10.1016/j.ultrasmedbio.2020.01.032.
Giles SL, Brown MRD, Rivens I, Deppe M, Huisman M, Kim YS, Farquhar-Smith P, Williams JE, Ter Haar GR, deSouza NM. Comparison of Imaging Changes and Pain Responses in Patients with Intra- or Extraosseous Bone Metastases Treated Palliatively with Magnetic Resonance-Guided High-Intensity Focused Ultrasound. J Vasc Interv Radiol. 2019 May 14. pii: S1051-0443(19)30259-3. doi: 10.1016/j.jvir.2019.02.019. [Epub ahead of print] PMID: 31101417
Bitton RR, Webb TD, Pauly KB, Ghanouni P. Prolonged Heating in Nontargeted Tissue During MR-guided Focused Ultrasound of Bone Tumors. J Magn Reson Imaging. 2019 Apr 5. doi: 10.1002/jmri.26726. [Epub ahead of print] PMID: 30950554
Gennaro N, Sconfienza LM, Ambrogi F, Boveri S, Lanza E. Thermal ablation to relieve pain from metastatic bone disease: a systematic review. Skeletal Radiol. 2019 Jan 9. doi: 10.1007/s00256-018-3140-0. [Epub ahead of print] Review. PMID: 30627778
Bertrand AS, Iannessi A, Natale R, Beaumont H, Patriti S, Xiong-Ying J, Baudin G, Thyss A. Focused ultrasound for the treatment of bone metastases: effectiveness and feasibility. J Ther Ultrasound. 2018 Nov 30;6:8. doi: 10.1186/s40349-018-0117-3. eCollection 2018. PMID: 30519467
Bucknor MD, Goel H, Pasco C, Horvai AE, Kazakia GJ. Bone remodeling following MR-guided focused ultrasound: Evaluation with HR-pQCT and FTIR. Bone. 2019 Mar;120:347-353. doi: 10.1016/j.bone.2018.11.009. Epub 2018 Nov 16. PMID: 30453088
Scipione R, Anzidei M, Bazzocchi A, Gagliardo C, Catalano C, Napoli A. HIFU for Bone Metastases and other Musculoskeletal Applications. Semin Intervent Radiol. 2018 Oct;35(4):261-267. doi: 10.1055/s-0038-1673363. Epub 2018 Nov 5. Review.
Bing F, Vappou J, de Mathelin M, Gangi A. Targetability of osteoid osteomas and bone metastases by MR-guided high intensity focused ultrasound (MRgHIFU). Int J Hyperthermia. 2018 Sep 13:1-9. doi: 10.1080/02656736.2018.1508758.
Chen ZQ, Wang CR, Ma XJ, Sun W, Shen JK, Sun MX, Fu ZZ, Hua YQ, Cai ZD. Evaluation of Quality of Life Using EORTC QLQ-BM22 in Patients with Bone Metastases after Treatment with Magnetic Resonance Guided Focused Ultrasound. Orthop Surg. 2018 Aug;10(3):264-271. doi: 10.1111/os.12383. Epub 2018 Jul 18.
Giles SL, Winfield JM, Collins DJ, Rivens I, Civale J, Ter Haar GR, deSouza NM. Value of diffusion-weighted imaging for monitoring tissue change during magnetic resonance-guided high-intensity focused ultrasound therapy in bone applications: an ex-vivo study. Eur Radiol Exp. 2018;2(1):10. doi: 10.1186/s41747-018-0041-x. Epub 2018 May 10.
Eisenberg E, Shay L, Keidar Z, Amit A, Militianu D. Magnetic Resonance-Guided Focused Ultrasound Surgery for Bone Metastasis: From Pain Palliation to Biological Ablation? J Pain Symptom Manage. 2018 Jul;56(1):158-162. doi: 10.1016/j.jpainsymman.2018.04.002. Epub 2018 Apr 19.
Sharma KV, Yarmolenko PS, Eranki A, Partanen A, Celik H, Kim A, Oetgen M, Kim PCW. Magnetic Resonance Imaging-guided High-intensity Focused Ultrasound Applications in Pediatrics: Early Experience at Children's National Medical Center. Top Magn Reson Imaging. 2018 Feb;27(1):45-51.
Dababou S, Marrocchio C, Scipione R, Erasmus HP, Ghanouni P, Anzidei M, Catalano C, Napoli A. High-Intensity Focused Ultrasound for Pain Management in Patients with Cancer. Radiographics. 2018 Mar-Apr;38(2):603-623. doi: 10.1148/rg.2018170129. Epub 2018 Jan 30.
Harding D, Giles SL, Brown MRD, Ter Haar GR, van den Bosch M, Bartels LW, Kim YS, Deppe M, deSouza NM. Evaluation of Quality of Life Outcomes Following Palliative Treatment of Bone Metastaseswith Magnetic Resonance-guided High Intensity Focused Ultrasound: An International Multicentre Study. Clin Oncol (R Coll Radiol). 2018 Apr;30(4):233-242. doi: 10.1016/j.clon.2017.12.023. Epub 2018 Jan 6.
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