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 summary of the first four patients has been published.

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 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
Blog: Beating Breast Cancer – My Hope for Focused Ultrasound

Help us revolutionize treatment for breast cancer by funding studies that will develop strategies for both early-and later-stage disease.
See the case statement >

Notable Papers

Meng Y, Reilly R, Pezo R, Trudeau M, Sahgal A, Singnurkar A, Perry J, Myrehaug S, Pople C, Davidson B, Llinas M, Hyen C, Huang Y, Hamani C, Suppiah S, Hynynen K, and Lipsman N. MR-guided focused ultrasound enhances delivery of trastuzumab to Her2-positive brain metastases. Science Translational Medicine 13 Oct 2021 Vol 13, Issue 615 DOI: 10.1126/scitranslmed.abj4011

Dhamija E, Singh R, Mishra S, Hari S. Image-Guided Breast Interventions: Biopsy and Beyond. Indian J Radiol Imaging. 2021 Apr;31(2):391-399. doi: 10.1055/s-0041-1734223. Epub 2021 Jul 28.

Fant C, Granzotto A, Mestas JL, Ngo J, Lafond M, Lafon C, Foray N, Padilla F. DNA Double-Strand Breaks in Murine Mammary Tumor Cells Induced by Combined Treatment with Doxorubicin and Controlled Stable Cavitation. Ultrasound Med Biol. 2021 Jul 24:S0301-5629(21)00258-1. doi: 10.1016/j.ultrasmedbio.2021.05.028.

Sanchez M, Barrere V, Treilleux I, Chopin N, Melodelima D. Development of a noninvasive HIFU treatment for breast adenocarcinomas using a toroidal transducer based on preliminary attenuation measurements. Ultrasonics. 2021 May 9;115:106459. doi: 10.1016/j.ultras.2021.106459.

Zhang Q, Wang W, Shen H, Tao H, Wu Y, Ma L, Yang G, Chang R, Wang J, Zhang H, Wang C, Zhang F, Qi J, Mi C. Low-Intensity Focused Ultrasound-Augmented Multifunctional Nanoparticles for Integrating Ultrasound Imaging and Synergistic Therapy of Metastatic Breast Cancer. Nanoscale Res Lett. 2021 Apr 29;16(1):73. doi: 10.1186/s11671-021-03532-z.

Tolba MF, Elghazaly H, Bousoik E, Elmazar MMA, Tolaney SM. Novel combinatorial strategies for boosting the efficacy of immune checkpoint inhibitors in advanced breast cancers. Clin Transl Oncol. 2021 Apr 19. doi: 10.1007/s12094-021-02613-w.

van de Voort EMF, Struik GM, Birnie E, Moelker A, Verhoef C, Klem TMAL. Thermal Ablation as an Alternative for Surgical Resection of Small ( 2 cm) Breast Cancers: A Meta-Analysis. Clin Breast Cancer. 2021 Mar 17:S1526-8209(21)00059-8. doi: 10.1016/j.clbc.2021.03.004.

Cohen G, Chandran P, Lorsung RM, Aydin O, Tomlinson LE, Rosenblatt RB, Burks SR, Frank JA. Pulsed-Focused Ultrasound Slows B16 Melanoma and 4T1 Breast Tumor Growth through Differential Tumor Microenvironmental Changes. Cancers (Basel). 2021 Mar 27;13(7):1546. doi: 10.3390/cancers13071546.

Cressey P, Amrahli M, So PW, Gedroyc W, Wright M, Thanou M. Image-guided thermosensitive liposomes for focused ultrasound enhanced co-delivery of carboplatin and SN-38 against triple negative breast cancer in mice. Biomaterials. 2021 Mar 16;271:120758. doi: 10.1016/j.biomaterials.2021.120758.

Si Y, Yue J, Liu Z, Li M, Du F, Wang X, Dai Z, Hu N, Ju J, Gao S, Wang X, Yuan P. Phase-Transformation Nanoparticle-Mediated Sonodynamic Therapy: An Effective Modality to Enhance Anti-Tumor Immune Response by Inducing Immunogenic Cell Death in Breast Cancer. Int J Nanomedicine. 2021 Mar 5;16:1913-1926. doi: 10.2147/IJN.S297933. eCollection 2021.

Amrahli M, Centelles M, Cressey P, Prusevicius M, Gedroyc W, Xu XY, So PW, Wright M, Thanou M. MR-labelled liposomes and focused ultrasound for spatiotemporally controlled drug release in triple negative breast cancers in mice. Nanotheranostics. 2021 Jan 1;5(2):125-142. doi: 10.7150/ntno.52168. eCollection 2021.

Feril LB, Fernan RL, Tachibana K. High-Intensity Focused Ultrasound in the Treatment of Breast Cancer. Curr Med Chem. 2020 Nov 11. doi: 10.2174/0929867327666201111143206.

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.

Click here for additional references from PubMed.

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