Focused Ultrasound Therapy

FDA Approved squareFocused 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.

Outside Approval SquareFor 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.

Clinical Trials SquareTreatments 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.

Clinical Trials

There is a phase IV, post approval clinical trial at many centers in the US that is looking at the pain palliation when magnetic resonance guided focused ultrasound is used to treat bone metastasis.

There is a clinical trial in Canada that is treating bone metastasis in children ages 5-17.

For a full list of known bone metastases clinical trials, please see here.

See a list of treatment sites >
See a list of laboratory research sites >

Notable Papers

Han X, Huang R, Meng T, Yin H, Song D. The Roles of Magnetic Resonance-Guided Focused Ultrasound in Pain Relief in Patients With Bone Metastases: A Systemic Review and Meta-Analysis. Front Oncol. 2021 Aug 11;11:617295. doi: 10.3389/fonc.2021.617295. eCollection 2021.

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.

Click here for additional references from PubMed.

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