Breast Tumors, Benign

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Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with benign breast tumors. Most of the work done has been on breast fibroadenoma. 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 precise ablation (thermal destruction of tissue) enabling breast fibroadenoma to be treated without surgery.

The primary options for treatment of breast fibroadenoma include invasive surgery.

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. There is also little to no scarring and minimal risk for breast deformation, and focused ultrasound therapy allows for a shorter recovery time. 

Clinical Trials

clinical trial in New York is using focused ultrasound to treat breast fibroadenoma.

multi-site clinical trial is being conducted using focused ultrasound to treat breast fibroadenoma. 

An additional study treating breast fibroadenoma with focused ultrasound in Bulgaria has been completed. 

See a full list of breast fibroadenoma clinical trials >

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

Regulatory Approval and Reimbursement

The Theraclion Echopulse system has received approval in Europe and Korea for the treatment of breast fibroadenoma. To the best of our knowledge, this is the only device approved for this indication.

To the best of our knowledge, focused ultrasound treatment for breast fibroadenoma is not reimbursed universally by medical insurers.

Notable Papers

Liu D, Shen G, Tang N, Lu H, Wei B. Robotic system for magnetic resonance imaging-guided high-intensity focus ultrasound application: Feasibility of breast fibroadenoma treatment. Int J Med Robot. 2023 Aug;19(4):e2519. doi: 10.1002/rcs.2519. Epub 2023 Apr 20. PMID: 37081747 

Liang M, Zhang C, Xia T, Chen R, Wang X, Weng M, Xie H, Chen L, Liu X, Wang S. Ultrasound radiomics features predicting the dosimetry for focused ultrasound surgery of benign breast tumor: A retrospective study. Front Genet. 2022 Sep 6;13:969409. doi: 10.3389/fgene.2022.969409. eCollection 2022. 

Co M, Chen C, Lee C, Yu S, Kwong A. Prospective clinical trial on the learning curve of high-intensity-focused ultrasound for the treatment of breast fibroadenoma. Surg Today. 2022 Jan 9. doi: 10.1007/s00595-021-02421-3.  

Saharkhiz N, Ha R, Taback B, Li XJ, Weber R, Nabavizadeh A, Lee SA, Hibshoosh H, Gatti V, Kamimura HAS, Konofagou EE. Harmonic motion imaging of human breast masses: an in vivo clinical feasibility. Sci Rep. 2020 Sep 17;10(1):15254. doi: 10.1038/s41598-020-71960-5. 

David R Brenin, MD, James Patrie, MS, Jonathan Nguyen, MD, Carrie M Rochman, MD. Treatment of Breast Fibroadenoma with Ultrasound-Guided High-Intensity Focused Ultrasound Ablation: A Feasibility Study. Journal of Breast Imaging, Volume 1, Issue 4, December 2019, Pages 316–323, 

Zhang Y, Yong L, Luo Y, Ding X, Xu D, Gao X, Yan S, Wang Q, Luo J, Pu D, Zou J. Enhancement of HIFU ablation by sonosensitizer-loading liquid fluorocarbon nanoparticles with pre-targeting in a mouse model. Sci Rep. 2019 May 6;9(1):6982. doi: 10.1038/s41598-019-43416-y. 

Imankulov S, Tuganbekov T, Razbadauskas A, Seidagaliyeva Z. HIFU treatment for fibroadenoma – a clinical study at National Scientific Research Centre, Astana, Kazakhstan. J Pak Med Assoc. 2018 Sep;68(9):1378-1380. 

Hahn M, Fugunt R, Schoenfisch B, Oberlechner E, Gruber IV, Hoopmann U, Roehm C, Helms G, Taran FA, Hartkopf AD, Warzecha H, Wiesinger B, Brucker SY, Boeer B. High intensity focused ultrasound (HIFU) for the treatment of symptomatic breast fibroadenoma. Int J Hyperthermia. 2018 Sep 11:1-8. doi: 10.1080/02656736.2018.1508757. 

Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017. 
Peek MC, Ahmed M, Scudder J, Baker R, Pinder SE, Douek M; HIFU-F Trialists’ Group. High intensity focused ultrasound in the treatment of breast fibroadenomata: results of the HIFU-F trial. Int J Hyperthermia. 2016 Dec;32(8):881-888. Epub 2016 Sep 7. 
Han Y, Wang S, Hibshoosh H, Taback B, Konofagou E. Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). Breast Cancer Res. 2016 May 9;18(1):46. doi: 10.1186/s13058-016-0707-3. 

Farrer AI, Almquist S, Dillon CR, Neumayer LA, Parker DL, Christensen DA, Payne A. Phase aberration simulation study of MRgFUS breast treatments. Med Phys. 2016 Mar;43(3):1374. doi: 10.1118/1.4941013. 
Click here for additional references from PubMed. 

Video courtesy of Theraclion

International Approval
Clinical Trials