Outside Approval Square

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 breast cancer. This novel technology focuses beams of ultrasound energy precisely and accurately on targets 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 precise ablation (thermal destruction of tissue). The goal could be complete ablation of the cancer, or it can be done partially. Partial ablation may help awaken the immune system for a more generalized response. A second mechanism is to promote the targeted release of therapeutic treatments in the region of the tumor.

Clinical Trials SquareAdvantages
Current treatment options for breast cancer include combinations of surgery, radiation, chemotherapy, hormone therapy or targeted drug therapies.

Focused ultrasound - used alone and in combination with other therapies - is being investigated to treat breast cancer.

Potential advantages as compared to current treatments:

  • Focused ultrasound is noninvasive and therefore has reduced risk for infection and blood clots, and potential for shorter recovery time.
  • Precise targeting minimizes damage to non-targeted healthy tissue.
  • No ionizing radiation, enabling repeat treatment if necessary.
  • Treatment can be a complement to drug therapy, enabling enhanced delivery of chemotherapy or immunotherapy to tumors.
  • May potentially induce an anti-tumor immune response.

Clinical Trials

See a list of clinical trials assessing focused ultrasound for treatment of breast cancer >

A clinical trial is evaluating the use of high-intensity focused ultrasound combined with pembrolizumab in patients with metastatic breast cancer at the University of Virginia. 

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

A clinical trial of patients with breast cancer is recruiting patients in France. This study is treating patients with breast cancer prior to surgical removal.

A clinical trial for patients with breast cancer that has metastasized to their brain has begun enrolling patients in Canada. The team will us focused ultrasound to open the blood brain barrier to allow therapeutic medications to more effectively reach the tumor in their brain. This study is only open to Canadian citizens.

A clinical trial for patients with breast cancer that is locally advanced or includes the chest wall has begun in Canada. This study uses a combination of focused ultrasound and radiation. This study is only open to Canadian citizens.

A clinical trial for patients with breast cancer that are planning a surgical resection is underway in Switzerland.

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

A clinical trial in Utrecht, Netherlands is using focused ultrasound for ablation of breast cancer prior to surgical resection.

A second clinical trial in Utrecht, Netherlands is using focused ultrasound for hyperthermia to help targeted drug therapy for patients with breast cancer.

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

Regulatory Approval and Reimbursement

The Model JC system manufactured by Chongqing Haifu has been approved in Europe, Russia, and China treatment of breast cancer.

Focused ultrasound treatment for patients with breast cancer is not universally reimbursed by medical insurers.

Preclinical Laboratory Studies

Preclinical studies are underway to investigate the use of non-ablation mechanisms of focused ultrasound in the treatment of breast cancer. Examples of these studies include:

  • Focused ultrasound to induce an immune response that could be combined with immunotherapeutics (e.g. checkpoint inhibitors) to treat both local and systemic disease.
  • Focused ultrasound to enable targeted delivery and/or activation of drugs via carrier vehicles (e.g. microbubbles, nanoparticles, liposomes) to enable delivery of high concentrations in the tumor with minimal systemic side effects.

Additional Resources

American Cancer Society
National Cancer Institute

Notable Papers

Sheybani ND, Witter AR, Thim EA, Yagita H, Bullock TNJ, Price RJ. Combination of thermally ablative focused ultrasound with gemcitabine controls breast cancer via adaptive immunity. J Immunother Cancer. 2020 Aug;8(2):e001008. doi: 10.1136/jitc-2020-001008.

Payne A, Merrill R, Minalga E, Hadley R, Odeen H, Hofstetter L, Johnson S, Tunon de Lara C, Auriol S, Recco S, Dumont E, Parker DL, Palussiere J. A breast-specific MR guided focused ultrasound platform and treatment protocol: first-in-human technical evaluation. IEEE Trans Biomed Eng. 2020 Aug 12;PP. doi: 10.1109/TBME.2020.3016206.

Peek MCL, Wu F. High-intensity focused ultrasound in the treatment of breast tumors. Ecancermedicalscience 2018;12:794.

Okita K, Narumi R, Azuma T, Furusawa H, Matsumoto Y, et al. Effects of breast structure on high- intensity focused ultrasound focal error. J Ther Ultrasound 2018;6:4.

Xiong J, Jiang B, Luo Y, Zou J, Gao X, Xu D, Du Y, Hao L. Multifunctional Nanoparticles Encapsulating Astragalus Polysaccharide and Gold Nanorods in Combination with Focused Ultrasound for the Treatment of Breast Cancer. Int J Nanomedicine. 2020 Jun 12;15:4151-4169. doi: 10.2147/IJN.S246447. eCollection 2020.

Kim D, Han J, Park SY, Kim H, Park JH, Lee HJ. Antitumor Efficacy of Focused Ultrasound-MFL Nanoparticles Combination Therapy in Mouse Breast Cancer Xenografts. Materials (Basel). 2020 Mar 2;13(5). pii: E1099. doi: 10.3390/ma13051099.

Hans-Christian Kolberg, MD, PhD and Cornelia Kolberg-Liedtke, MD, PhD High Focused Ultrasound in a Case of Previously Untreated Breast Cancer Clinical Medical Reviews and Case Reports. Vol 6 Issue 2. DOI: 10.23937/2378-3656/1410256

Farrokh D, Fallah-Rastegar Y, Abbasi B. Pseudoaneurysm of the breast after core needle biopsy: Successful treatment with focused ultrasound-guided compression. Breast J. 2019 Mar;25(2):312-313. doi: 10.1111/tbj.13215. Epub 2019 Feb 21.

Snipstad S, Berg S, Mørch Ý, Bjørkøy A, Sulheim E, Hansen R, Grimstad I, van Wamel A, Maaland AF, Torp SH, Davies CL. Ultrasound Improves the Delivery and Therapeutic Effect of Nanoparticle-Stabilized Microbubbles in Breast Cancer Xenografts. Ultrasound Med Biol. 2017 Nov;43(11):2651-2669. doi: 10.1016/j.ultrasmedbio.2017.06.029. Epub 2017 Aug 3.

Knuttel FM, Huijsse SEM, Feenstra TL, Moonen CTW, van den Bosch MAAJ, Buskens E, Greuter MJW, de Bock GH. Early health technology assessment of magnetic resonance-guided high intensity focused ultrasound ablation for the treatment of early-stage breast cancer. J Ther Ultrasound. 2017 Aug 1;5:23. doi: 10.1186/s40349-017-0101-3. eCollection 2017.

Peek MC, Ahmed M, Napoli A, Usiskin S, Baker R, Douek M. Minimally invasive ablative techniques in the treatment of breast cancer: a systematic review and meta-analysis. Int J Hyperthermia. 2016 Oct 2:1-12.

Merckel LG, Knuttel FM, Deckers R, van Dalen T, Schubert G, Peters NH, Weits T, van Diest PJ, Mali WP, Vaessen PH, van Gorp JM, Moonen CT, Bartels LW, van den Bosch MA. First clinical experience with a dedicated MRI-guided high-intensity focused ultrasound system for breast cancer ablation. Eur Radiol. 2016 Feb 6.

Alkins R, Burgess A, Kerbel R, Wels WS, Hynynen K. Early treatment of HER2-amplified brain tumors with targeted NK-92 cells and focused ultrasound improves survival. Neuro Oncol. 2016 Jan 26. pii: nov318.

Peek MC, Ahmed M, Pinder SE, Douek M. A review of ablative techniques in the treatment of breast fibroadenomata. J Ther Ultrasound. 2016 Jan 19;4:1. doi: 10.1186/s40349-016-0045-z. eCollection 2016.

Knuttel FM, Waaijer L, Merckel LG, van den Bosch MA, Witkamp AJ, Deckers R, van Diest PJ. Histopathology of breast cancer after magnetic resonance-guided high intensity focused ultrasound and radiofrequency ablation. Histopathology. 2016 Jan 5. doi: 10.1111/his.12926.

Li S, Wu PH. Comparison of magnetic resonance- and ultrasound-guided high-intensity focused ultrasound in the treatment of breast cancer. Chin J Cancer. 2013 Aug;32(8):441-52. Epub2012 Dec 14.

Click here for additional references from PubMed.

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