Focused Ultrasound Therapy
Breast Cancer
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 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.
Benign Breast Disease
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.
Benefits
Current treatment options for breast cancer include combinations of surgery, radiation, chemotherapy, hormone therapy and immunotherapy. Less invasive surgical options such as radiofrequency ablation, cryotherapy, and laser ablation are gaining traction as alternatives to open surgeries as they afford the patient improved cosmetic results and decreased morbidity. Focused ultrasound — used alone or in combination with other therapies — is now treating breast cancer given the benefits that are afforded to the patient.
Advantages:
- Noninvasive – no incisions, no risk of infection or bleeding, less pain, and rapid recovery
- Image-guided – precision targeting and minimal damage to surrounding healthy tissue
- No ionizing radiation – fewer side effects and can be safely repeated
- Targeted delivery of drugs and other therapeutic agents – increasing effectiveness and decreasing toxicity
- Initiation of an anti-tumor immune response – destruction of tumor cells leads to exposure of tumor antigens, which can then be recognized and targeted by the body’s immune system
- Directly enhances the effectiveness of immuno-oncology drugs
Regulatory Authorizations
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 disease is not universally reimbursed by medical insurers.
Clinical Trials
Breast Cancer
A clinical trial in Canada is combining the use of radiation therapy with focused ultrasound for patients with advanced breast cancer.
A clinical trial in New York is treating benign and stage 1 malignant breast tumors.
A clinical trial is evaluating the use of high-intensity focused ultrasound combined with gemcitabine in patients with stage I-III breast cancer at the University of Virginia. This is a treatment followed by surgical resection.
A clinical trial in Utah is recruiting patients with breast cancer for focused ultrasound treatment. This is a treatment followed by surgical resection.
A clinical trial in China is using high intensity focused ultrasound with multiple other therapeutic agents in an effort to treat patients with triple negative breast cancer.
A clinical trial in China is using high intensity focused ultrasound for treatment of breast cancer patients.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
Benign Breast Disease
A clinical trial in New York is using focused ultrasound to treat breast fibroadenoma.
A multi-site clinical trial is being conducted using focused ultrasound to treat breast fibroadenoma.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
See a list of treatment sites >
See a list of laboratory research sites >
Preclinical Laboratory Studies
Preclinical studies are underway to investigate the use of non-ablation mechanisms of focused ultrasound in the treatment of breast disease. Examples of these studies include:
- *Improving of bioeffects during FUS-microbubble treatments (University of Virginia)
- *Targeting immunosuppressive myeloid cells to increase the efficacy of thermally ablative FUS in breast cancer (University of Virginia)
- *Focused ultrasound stimulation of the immune response in a breast cancer model (Inserm LabTAU,France)
- *Preclinical HIFU treatment of breast adenocarcinoma using a non-invasive toroidal transducer (Inserm LabTAU, France)
- *Biomechanical modulation of inflammation with FUS for breast cancer therapy (Vanderbilt University)
- *Turning Up the Heat: Using Focused Ultrasound to Shift the Immunosuppressive Breast Cancer Tumor Microenvironment from “Cold” to “Hot”, Augmenting Systemic Anti-Tumor Immune Activation (Virginia Polytechnic Institute and State University)
*The Focused Ultrasound Foundation is partially or fully funding these studies.
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 >
Manufacturers
- Changjiangyuan Technology Development Co., Ltd. | Beijing, China | www.shubodao.com
- Chongqing Haifu Medical Technology Co., Ltd. | Chongqing, China | www.haifumedical.com
- Image Guided Therapy, SA. | Pessac. France | www.imageguidedtherapy.com
- INSIGHTEC, Ltd. | Haifa, Israel | www.insightec.com/us
- Profound Medical | Ontario, Canada | www.profoundmedical.com
- Shanghai A&S Science Technology Development Co., Ltd. | Shanghai, China
- Theraclion | Malakoff, France | www.theraclion.com
Media & Videos
For Breast Cancer, Can Focused Ultrasound Overcome Immunotherapy’s Limitations?
UVA Health – November 21, 2023
Focused ultrasound ablation for treatment of breast tumors
Healthcare-in-europe – January 18, 2023
Battling Breast Cancer with High-Intensity Focused Ultrasound
Excited By The Science by Edanz – July 3, 2023
New procedure to ‘kill’ breast lumps without surgery could be available in a few years
Today – October 26, 2023
Advancing Immunotherapy’s Reach With Focused Ultrasound
UVAHealth – October 17, 2023
Notable Papers
Huang X, Luo X, Su T, Su K, Peng S, Li H. Manganese-based metal-organic frameworks augment postoperative immunotherapy of high-intensity focused ultrasound. J Colloid Interface Sci. 2026 Apr 15;708:139847. doi: 10.1016/j.jcis.2026.139847. Epub 2026 Jan 6. PMID: 41518922
Wang H, Ning W, Wang H, Li H and Zhang G (2026) Acupoint glucocorticoid injection combined with focused ultrasound for granulomatous lobular mastitis: a retrospective study. Front. Surg. 13:1715357. doi: 10.3389/fsurg.2026.1715357
Li X, Li H, Mu C, Li H, Du Q, Liu W. Therapeutic effect of Xihuang capsules in combination with low-power high-intensity focused ultrasound on granulomatous mastitis and its impact on macrophage (CD68) and proliferative (Ki67) markers. Pak J Pharm Sci. 2025 Nov-Dec;38(6):2453-2461. doi: 10.36721/PJPS.2025.38.6.REG.15239.1. PMID: 41334659.
Zou X, Li S, Jin Z, Huang S, Niu R, Fu N, Li W, Gao J, Wang Z. An Injectable Thermosensitive Hydrogel Codelivering Permeability-Promoting Nintedanib-loaded Phase-transition Nanoparticles and Doxorubicin to Potentiate Immunogenic Cell Death in Triple-Negative Breast Cancer for Chemoimmunotherapy. ACS Appl Mater Interfaces. 2026 Feb 21. doi: 10.1021/acsami.5c26337. PMID: 41721732
Adams-Tew SI, Johnson A, Crockett J, Adams KE, Parker DL, Winkler N, Payne A. Impact of breast biopsy markers on magnetic resonance-guided focused ultrasound. Int J Hyperthermia. 2026 Dec;43(1):2632351. doi: 10.1080/02656736.2026.2632351. Epub 2026 Feb 23. PMID: 41725365
Liu Y, Hu S, Munot S, Konofagou EE. 3-D Handheld Harmonic Motion Imaging System for Breast Tumor Assessment: A Clinical Feasibility Study. Ultrasound Med Biol. 2026 Jan 27:S0301-5629(26)00001-3. doi: 10.1016/j.ultrasmedbio.2026.01.001. PMID: 41605726
Wu X, Pan F, Xiao Y, Chen M, Yin H, Mu D, Yang L, Yang H, Chen W, Zhang C. Factors influencing the volume reduction rate of ultrasound-guided high-intensity focused ultrasound for breast fibroadenoma. Int J Hyperthermia. 2026 Dec;43(1):2610775. doi: 10.1080/02656736.2025.2610775. Epub 2026 Jan 8. PMID: 41506619
Feng J, Tong Y, Zhang Z, He Y. Case Report: Pathological complete response yet early brain relapse in HER2-positive breast cancer: a case-based review. Front Immunol. 2026 Jan 5;16:1668995. doi: 10.3389/fimmu.2025.1668995. eCollection 2025. PMID: 41562063
Zhou Y, Huang X, Su T, Su K, Peng S, Li H. Hypoxia-specific metal-organic frameworks combined with lactate immunometabolism regulation augment anti-tumor immunity of HIFU. Mater Today Bio. 2025 Dec 15;36:102695. doi: 10.1016/j.mtbio.2025.102695. eCollection 2026 Feb. PMID: 41509979
Hu S, Liu Y, Wang R, Li X, Konofagou EE. A Multimodal Ultrasound-Driven Approach for Automated Tumor Assessment With B-Mode and Multi-Frequency Harmonic Motion Images. IEEE Trans Biomed Eng. 2026 Feb;73(2):498-509. doi: 10.1109/TBME.2025.3586250. PMID: 40614147
Yang T, Lou Y, Ying Z. Nanoparticle-ultrasound synergy: an emerging theranostic paradigm for breast and gynecologic cancers. Front Oncol. 2025 Dec 4;15:1617939. doi: 10.3389/fonc.2025.1617939. eCollection 2025. PMID: 41426324
Su X, Wang Y, Qin X, Xiao Y, Ouyang B, Hu L, Kang L, Xu R, Xu C, Sun Z, Sun C, Guo H, Pang Z, Shen S. HIFU-Driven Targeted Pyroptosis Therapy in Basal-Like Breast Cancer. Adv Sci (Weinh). 2025 Nov;12(44):e03830. doi: 10.1002/advs.202503830. Epub 2025 Sep 14. PMID: 40946176
Lee SN, Choi JH, Moon H, Kim D, Hong J, Lee HJ, Lim YT. Focused ultrasound-triggered doxorubicin liposomes reshape tumor microenvironment to boost checkpoint depletion in triple-negative breast cancer model. J Control Release. 2025 Dec 10;388(Pt 2):114389. doi: 10.1016/j.jconrel.2025.114389. Epub 2025 Nov 4. PMID: 41197832
Zhou D, Mu D, Lin Z, Ren Y, Zhou Y, Liu H, Zhu L, Luo J, Li M, Li C, Li F. Ultrasound radiomics-based nomogram to predict the non-perfused volume ratio of breast fibroadenomas treated with ultrasound-guided high-intensity focused ultrasound: a multicenter study. Int J Hyperthermia. 2025 Dec;42(1):2568624. doi: 10.1080/02656736.2025.2568624. Epub 2025 Oct 9. PMID: 41069014
Sengupta S, Bhattacharjee A, Basu B, Kar S, Moulik S. Ultrasound-Mediated Nanocarrier-Based Drug Delivery in Breast Cancer Therapy: Innovations and Outlook. J Ultrasound Med. 2025 Nov 17. doi: 10.1002/jum.70117. PMID: 41247034
Bates JG, Dillon CR, Jones MR, Tencer JT. Multifidelity Uncertainty Quantification for Focused Ultrasound Breast Cancer Therapies Using Reduced Order Models. ASME J Heat Mass Transf. 2025 Dec 1;147(12):121201. doi: 10.1115/1.4069124. Epub 2025 Aug 19. PMID: 41256765
Alikarami S, Harandi H, Jahanshahi A, Zakavi SS, Frounchi N, Ghavam M, Momtazmanesh S. High-Intensity Focused Ultrasound in Treatment of Primary Breast Cancer: A Systematic Review and Meta-Analysis. J Clin Ultrasound. 2025 Nov 24. doi: 10.1002/jcu.70143. PMID: 41287177
Wang H, Wang H, Ning W, Zhang G, Guo Q, Li K. Retrospective cohort study on the effects of corticosteroid combined with focused ultrasound therapy on lesion size and inflammatory markers in patients with granulomatous mastitis. Pak J Pharm Sci. 2025;38(6):2229-2237. doi: 10.36721/PJPS.2025.38.6.REG.13937.1. PMID: 41139272
Click here for additional references from PubMed.
Video courtesy of Insightec