Focused Ultrasound Therapy

Clinical Trials Square

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 a variety of diseases that may be treated in utero. 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 various biological effects enabling temporary or permanent repair to be made without surgery. Much of this work is still in the preclinical phase, but some of it has progressed to early patient treatment (neonatal twin-twin reversed perfusion).

Focused ultrasound is not currently an approved treatment for fetal birth defects but has been proposed as a potential noninvasive alternative to open surgery. Focused ultrasound has the ability to use acoustic energy to destroy target tissue through cavitation (histotripsy) or thermal ablation. This could help treat defects like twin-twin transfusion syndrome (ablation of vessels), fetal bladder obstructions and a range of CHDs (atrial-septal defects, valvuloplasty, tetralogy of fallot).

Some preclinical feasibility studies have yielded promising results for procedures including cardiac valve ablation, vascular occlusion and fetal tissue ablation. However, for research to progress past the preclinical and anecdotal stages, more studies are needed to further explore safety and efficacy.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost.

Advantages:

  • 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.
  • It can be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound intra-uterine treatments.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for intra-uterine conditions are not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Shaw CJ, Rivens I, Civale J, Botting KJ, Allison BJ, Brain KL, Niu Y, Ter Haar G, Giussani DA, Lees CC. Maternal and fetal cardiometabolic recovery following ultrasound-guided high-intensity focused ultrasound placental vascular occlusion. J R Soc Interface. 2019 May 31;16(154):20190013. doi: 10.1098/rsif.2019.0013. PMID: 31039691

Shaw CJ, Rivens I, Civale J, Botting KJ, Ter Haar G, Giussani DA, Lees CC. Trans-abdominal in vivo placental vessel occlusion using High Intensity Focused Ultrasound. Sci Rep. 2018 Sep 11;8(1):13631. doi: 10.1038/s41598-018-31914-4.

Seo K, Ichizuka K, Okai T, Dohi S, Nakamura M, Hasegawa J, Matsuoka R, Yoshizawa S, Umemura SI, Nagatsuka M, Sekizawa A. Twin-Reversed Arterial Perfusion Sequence Using High-Intensity Focused Ultrasound Therapy. Ultrasound Obstet Gynecol. 2018 Aug 22. doi: 10.1002/uog.20101.

Shaw CJ, ter Haar GR, Rivens IH, Giussani DA, Lees CC. Pathophysiological mechanisms of high-intensity focused ultrasound-mediated vascular occlusion and relevance to non-invasive fetal surgery. J R Soc Interface. 2014 Mar 26;11(95):20140029.

Okai T, Ichizuka K, Hasegawa J, Matsuoka R, Nakamura M, Shimodaira K, Sekizawa A, Kushima M, Umemura S. First successful case of non-invasive in-utero treatment of twin reversed arterial perfusion sequence by high-intensity focused ultrasound. Ultrasound Obstet Gynecol. 2013 Jul;42(1):112-4.

Griffiths A, terHaar G, Rivens I, Giussani D, Lees C. High-intensity focused ultrasound in obstetrics and gynecology: the birth of a new era of noninvasive surgery? Ultraschall Med. 2012 Dec;33(7):E8-15.

Ichizuka K, Hasegawa J, Nakamura M, Matsuoka R, Sekizawa A, Okai T, Umemura S. High-intensity focused ultrasound treatment for twin reversed arterial perfusion sequence. Ultrasound Obstet Gynecol. 2012 Oct;40(4):476-8.

Click here for additional references from PubMed.

 

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