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.

Advantages
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 in pediatric patients and young adults.

A clinical trial in Trondheim, Norway, is using focused ultrasound to pre-treat patients with metastatic lesions in their liver due to colorectal cancer before chemotherapy doses.

A clinical trial in Tours, France, is using focused ultrasound to enhance the penetration of therapeutic medications in patients who have liver metastatic lesions from colorectal cancer.

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

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

Tsang SH, Ma KW, She WH, Chu F, Lau V, Lam SW, Cheung TT, Lo CM. High-intensity focused ultrasound ablation of liver tumors in difficult locations. Int J Hyperthermia. 2021 Sep;38(2):56-64. doi: 10.1080/02656736.2021.1933217.

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.

Click here for additional references from PubMed.

Video courtesy of Insightec.

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