Breast Cancer

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. Where the beams converge, the ultrasound produces a variety of therapeutic effects enabling the patient to be treated without incisions or radiation.

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 non-invasive 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 Square

Clinical Trials

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

A trial at the University of Virginia is evaluating the use of high-intensity focused ultrasound combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after focused ultrasound and one-half of participants will be randomized to receive their first dose of pembrolizumab before focused ultrasound. More information on the study can be found here.

See here for a list of treatment sites
See here for a list of clinical trial sites
See here for a list of laboratory research sites

Regulatory Approval and Reimbursement

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

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

Pre-clinical Laboratory Studies

Pre-clinical 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

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.

Merckel LG, Bartels LW, Köhler MO, van den Bongard HJ, Deckers R, Mali WP, Binkert CA, Moonen CT, Gilhuijs KG, van den Bosch MA. MR-guided high-intensity focused ultrasound ablation of breast cancer with a dedicated breast platform. Cardiovasc Intervent Radiol.2013 Apr;36(2):292-301. Epub2012 Dec 12.

Wang SW, He XY, Li MZ. High-intensity focused ultrasound compared with irradiation for ovarian castration in premenopausal females with hormone receptor-positive breast cancer after radical mastectomy. Oncol Lett. 2012 Nov;4(5):1087-1091. Epub 2012 Aug 13.

Furusawa H, Namba K, Nakahara H, Tanaka C, Yasuda Y, Hirabara E, Imahariyama M, Komaki K. The evolving non-surgical ablation of breast cancer: MR guided focused ultrasound (MRgFUS). Breast Cancer 2007;14(1):55-8.

Wu F, Wang ZB, Cao YD, Zhu XQ, Zhu H, Chen WZ, Zou JZ. “Wide local ablation” of localized breast cancer using high intensity focused ultrasound. J Surg Oncol 2007 Aug 1;96(2):130-6.

Click here for additional references from PubMed.

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