Focused Ultrasound Therapy

Outside Approval SquareFocused 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 fibroadenoma. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. Where the beams converge, the 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 and lower cost.

Clinical Trials SquareAdvantages:

  • Focused ultrasound is noninvasive, so it does not carry added concerns like surgical wound healing or infection.
  • Focused ultrasound can reach the desired target without damaging surrounding tissue.
  • There is little to no scarring and minimal risk for breast deformation.
  • Fewer complications and shorter recovery time.

Clinical Trials

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

An additional study is treating breast fibroadenoma with focused ultrasound in Bulgaria. 

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

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

 

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