Focused Ultrasound Therapy

Outside Approval 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 liver tumors. 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 several therapeutic effects that are being evaluated.

One mechanism is the production of precise ablation (thermal destruction of tissue). This destruction can be done to completely destroy the target or to partially treat it, and partial treatment is believed to stimulate the patient’s immune response, which may have a broader impact.

Clinical Trials SquareAnother mechanism is the use of mechanical (non-thermal) histotripsy to destroy the tumor.

A third mechanism is to use focused ultrasound to cause hyperthermia which enables the local release and absorption of a therapeutic that is contained in the blood stream.

The primary options for treatment of liver tumors include surgery, chemotherapy, radiotherapy, localized destruction of the tumor tissue (via radiofrequency ablation, alcohol injection, cryosurgery, or laser photocoagulation), or combination of two or more of these options. The long-term solution for primary liver cancer is often liver transplantation.

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. Focused ultrasound can also enhance the chemotherapy dose for the target, with less impact to the rest of the patient.

Clinical Trials

There is a clinical trial for liver cancer and metastatic liver tumors in pediatric patients and young adults.

A second study involves enhancing drug delivery due to heating the thermosensitive lysosome containing chemotherapy with focused ultrasound.

A third clinical trial was recently completed. This study used cavitation-based energy for cellular destruction of hepatocellular carcinoma has completed enrollment. 

A fourth clinical trial is looking at using high intensity focused ultrasound on patients with liver metastatic disease.

A fifth clinical trial is recruiting patients with solid tumors with metastatic lesions, including liver cancer, at the University of Virginia.

A sixth clinical trial is recruiting patients for treatment of liver lesions from breast or colorectal cancer, where focused ultrasound is being used to enhance efficacy of chemotherapeutics.

A pair of clinical trials are using histotripsy to treat liver tumors. 

For a full list of clinical trials, please click here.

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

Regulatory Approval and Reimbursement

A focused ultrasound system has been approved in China, Russia, Europe, and Korea for treatment of liver cancer.

To the best of our knowledge, the use of focused ultrasound to treat liver cancer is not yet widely reimbursed by medical insurance.

Notable Papers

Merrill R, Odéen H, Dillon C, Bitton R, Ghanouni P, Payne A. Design and evaluation of an open-source, conformable skin-cooling system for body magnetic resonance guided focused ultrasound treatments. Int J Hyperthermia. 2021;38(1):679-690. doi: 10.1080/02656736.2021.1914872.

Barrere V, Sanchez M, Cambronero S, Dupré A, Rivoire M, Melodelima D. Evaluation of Ultrasonic Attenuation in Primary and Secondary Human Liver Tumors and Its Potential Effect on High-Intensity Focused Ultrasound Treatment. Ultrasound Med Biol. 2021 Apr 21:S0301-5629(21)00135-6. doi: 10.1016/j.ultrasmedbio.2021.03.014.

Hendricks A, Weber P, Simon A, Saunier S, Coutermarsh-Ott S, Grider D, Jove JV, Allen IC, Luyimbazi D, Vlaisavljevich E. Histotripsy for the Treatment of Cholangiocarcinoma Liver Tumors: In Vivo Feasibility and Ex Vivo Dosimetry Study. IEEE Trans Ultrason Ferroelectr Freq Control. 2021 Apr 15;PP. doi: 10.1109/TUFFC.2021.3073563.

Gu L, Shen Z, Ji L, Ng DM, Du N, He N, Fan X, Yan K, Zheng Z, Chen B, Ma L, Qiu G, Chen P, Zheng J, Yang T. High-intensity focused ultrasound alone or combined with transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with unsuitable indications for hepatectomy and radiofrequency ablation: a phase II clinical trial. Surg Endosc. 2021 Mar 31. doi: 10.1007/s00464-021-08465-3.

Wu L, Zhou J, Zhou W, Huang XF, Chen Q, Wang W, Zhai L, Li S, Tang Z. Sorafenib blocks the activation of the HIF-2alpha/VEGFA/EphA2 pathway, and inhibits the rapid growth of residual liver cancer following high-intensity focused ultrasound therapy in vivo. Pathol Res Pract. 2020 Dec 8;220:153270. doi: 10.1016/j.prp.2020.153270.

Ji Y, Zhu J, Zhu L, Zhu Y, Zhao H. High-Intensity Focused Ultrasound Ablation for Unresectable Primary and Metastatic Liver Cancer: Real-World Research in a Chinese Tertiary Center With 275 Cases. Front Oncol. 2020 Oct 29;10:519164. doi: 10.3389/fonc.2020.519164. eCollection 2020.

Keller SB, Suo D, Wang YN, Kenerson H, Yeung RS, Averkiou MA. Image-Guided Treatment of Primary Liver Cancer in Mice Leads to Vascular Disruption and Increased Drug Penetration. Front Pharmacol. 2020 Sep 30;11:584344. doi: 10.3389/fphar.2020.584344. eCollection 2020.

Sun M, Shang P, Bai J, Li S, Li M. High-intensity focused ultrasound ablation combined with transcatheter arterial chemoembolization improves long-term efficacy and prognosis of primary liver cancer. J Clin Lab Anal. 2020 Oct 25:e23633. doi: 10.1002/jcla.23633.

Battais A, Barrère V, N'Djin WA, Dupré A, Rivoire M, Melodelima D. Fast and Selective Ablation of Liver Tumors by High-Intensity Focused Ultrasound Using a Toroidal Transducer Guided by Ultrasound Imaging: The Results of Animal Experiments. Ultrasound Med Biol. 2020 Sep 2:S0301-5629(20)30350-1. doi: 10.1016/j.ultrasmedbio.2020.08.001.

Sehmbi AS, Froghi S, Oliveira de Andrade M, Saffari N, Fuller B, Quaglia A, Davidson B. Systematic review of the role of high intensity focused ultrasound (HIFU) in treating malignant lesions of the hepatobiliary system. HPB (Oxford). 2020 Aug 20:S1365-182X(20)31102-3. doi: 10.1016/j.hpb.2020.06.013.

Daunizeau L, Nguyen A, Le Garrec M, Chapelon JY, N'Djin WA. Robot-assisted ultrasound navigation platform for 3D HIFU treatment planning: Initial evaluation for conformal interstitial ablation. Comput Biol Med. 2020 Aug 1;124:103941. doi: 10.1016/j.compbiomed.2020.103941.

Jin C, Yang W, Ran L, Zhang J, Zhu H. Feasibility of High-Intensity Focused Ultrasound for Hepatocellular Carcinoma after Stereotactic Body Radiation Therapy: Initial Experience. Ultrasound Med Biol. 2020 Jul 31:S0301-5629(20)30285-4. doi: 10.1016/j.ultrasmedbio.2020.06.013.

Qiao W, Yu Y, Huang Y, Gao W, Liu Z. Impact of focused ultrasound on the ethanol ablation of VX2 liver tumours in rabbits. Eur Radiol. 2020 Jun 12. doi: 10.1007/s00330-020-06941-3.

Barrere V, Melodelima D, Catheline S, Giammarinaro B. Imaging of Thermal Effects during High-Intensity Ultrasound Treatment in Liver by Passive Elastography: A Preliminary Feasibility in Vitro Study. Ultrasound Med Biol. 2020 Jun 1:S0301-5629(20)30135-6. doi: 10.1016/j.ultrasmedbio.2020.03.019.

Yang T, Ng DM, Du N, He N, Dai X, Chen P, Wu F, Chen B, Fan X, Yan K, Zhou X, Dong M, Zheng Z, Gu L. HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial. Surg Endosc. 2020 May 20. doi: 10.1007/s00464-020-07644-y.

Khokhlova TD, Schade GR, Wang YN, Buravkov SV, Chernikov VP, Simon JC, Starr F, Maxwell AD, Bailey MR, Kreider W, Khokhlova VA. Pilot in vivo studies on transcutaneous boiling histotripsy in porcine liver and kidney. Sci Rep. 2019 Dec 27;9(1):20176. doi: 10.1038/s41598-019-56658-7.

Mohammadpour M, Firoozabadi B. Numerical study of the effect of vascular bed on heat transfer during high intensity focused ultrasound (HIFU) ablation of the liver tumor. J Therm Biol. 2019 Dec;86:102431. doi: 10.1016/j.jtherbio.2019.102431. Epub 2019 Oct 7.

Zhang Q, Bian SQ, Lv W, Kou D, Hu HL, Guo SS, Cao ZS. Observation of efficacy of TACE combined with HIFU on patients with middle-advanced liver cancer. Eur Rev Med Pharmacol Sci. 2019 Aug;23(3 Suppl):239-246. doi: 10.26355/eurrev_201908_18653.

Zhang H, He X, Yu J, Song W, Liu X, Liu Y, Zhou J, Guo D. Preoperative MRI features and clinical laboratory indicators for predicting the early therapeutic response of hepatocellular carcinoma to transcatheter arterial chemoembolization combined with High-intensity focused ultrasound treatment. Br J Radiol. 2019 Jun 5:20190073. doi: 10.1259/bjr.20190073. [Epub ahead of print] PMID: 31166700

Luo Y, Jiang Y. Comparison of Efficiency of TACE plus HIFU and TACE alone on Patients with Primary Liver Cancer. J Coll Physicians Surg Pak. 2019 May;29(5):414-417. doi: 10.29271/jcpsp.2019.05.414.

Li S, Shi S, Li A, Liu H, Cai L. Diffusion-Weighted Magnetic Resonance Imaging in Assessment of Primary Liver Cancer after HIFU Treatment. J Coll Physicians Surg Pak. 2019 Apr;29(4):305-308. doi: 10.29271/jcpsp.2019.04.305.

Dupre A, Melodelima D, Perol D, Chen Y, Vincenot J, Chapelon JY, Rivoire M. Evaluation of the Feasibility, Safety, and Accuracy of an Intraoperative High-intensity Focused Ultrasound Device for Treating Liver Metastases. J Vis Exp. 2019 Jan 9;(143). doi: 10.3791/57964.

Huang L, Zhou K, Zhang J, Ma Y, Yang W, Ran L, Jin C, Dimitrov DD, Zhu H. Efficacy and safety of high-intensity focused ultrasound ablationfor hepatocellular carcinoma by changing the acoustic environment: microbubble contrast agent (SonoVue) and transcatheter arterial chemoembolization. Int J Hyperthermia. 2019 Jan 22:1-9. doi: 10.1080/02656736.2018.1558290.

Gray MD, Lyon PC, Mannaris C, Folkes LK, Stratford M, Campo L, Chung DYF, Scott S, Anderson M, Goldin R, Carlisle R, Wu F, Middleton MR, Gleeson FV, Coussios CC. Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from a Phase I Trial. Radiology. 2019 Jan 15:181445. doi: 10.1148/radiol.2018181445.

Wang L, Li L, Wang X, Zhao D, Shan G, Wu X, Wang M, Liu J, Li X. Comparison of Combination Stereotactic Body Radiotherapy Plus High-Intensity Focused Ultrasound Ablation Versus Stereotactic Body Radiotherapy Alone for Massive Hepatocellular Carcinoma. Med Sci Monit. 2018 Nov 18;24:8298-8305. doi: 10.12659/MSM.910735.

Ma B, Liu X, Yu Z. The effect of high intensity focused ultrasound on the treatment of liver cancer and patients' immunity. Cancer Biomark. 2018 Oct 9. doi: 10.3233/CBM-181822. 

Wang L, Li L, Wang X, Zhao D, Shan G, Wu X, Wang M, Liu J, Li X. Comparison of Combination Stereotactic Body Radiotherapy Plus High-Intensity Focused Ultrasound Ablation Versus Stereotactic Body Radiotherapy Alone for Massive Hepatocellular Carcinoma. Med Sci Monit. 2018 Nov 18;24:8298-8305. doi: 10.12659/MSM.910735.

Lyon PC, Gray MD, Mannaris C, Folkes LK, Stratford M, Campo L, Chung DYF, Scott S, Anderson M, Goldin R, Carlisle R, Wu F, Middleton MR, Gleeson FV, Coussios CC. Safety and feasibility of ultrasound-triggered targeted drug delivery of doxorubicin from thermosensitive liposomes in liver tumours (TARDOX): a single-centre, open-label, phase 1 trial. Lancet Oncol. 2018 Aug;19(8):1027-1039. doi: 10.1016/S1470-2045(18)30332-2. Epub 2018 Jul 11.

Paul C. Lyon, Lucy F. Griffiths, Jenni Lee, Daniel Chung, Robert Carlisle, Feng Wu, Mark R. Middleton Email author, Fergus V. Gleeson and Constantin C. Coussios. Clinical trial protocol for TARDOX: a phase I study to investigate the feasibility of targeted release of lyso-thermosensitive liposomal doxorubicin (ThermoDox®) using focused ultrasound in patients with liver tumours. Journal of Therapeutic Ultrasound. 20175:28

Zhai YP1, Wang Y. Effect of the combination treatment of high-intensity focused ultrasound and cryocare knife in advanced liver cancer. J BUON. 2017 Mar-Apr;22(2):495-499.

Wu L, Zhang YS, Ye ML, Shen F, Liu W, Hu HS, Li SW, Wu HW, Chen QH, Zhou WB. Overexpression and correlation of HIF-2α, VEGFA and EphA2 in residual hepatocellular carcinoma following high-intensity focused ultrasound treatment: Implications for tumor recurrence and progression. Exp Ther Med. 2017 Jun;13(6):3529-3534. doi: 10.3892/etm.2017.4428. Epub 2017 May 4.

Click here for additional references from PubMed.

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