Focused Ultrasound Therapy

Outside Approval 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 soft tissue tumors. This novel technology focuses beams of ultrasonic 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 several therapeutic effects that are being evaluated. One is precise ablation (thermal destruction of tissue). This destruction can be done to completely destroy the target or to partially treat it. Partial treatment is believed to stimulate the patient’s immune response, which may have a broader impact. Another mechanism is to produce local hyperthermia of the targeted tissue, which can have a variety of beneficial effects including the release of chemotherapy drugs that are contained in temperature sensitive therapeutic molecules. This allows delivery of a higher level of chemotherapy precisely to the targeted tissue, while limiting the effects for the rest of the body.

Advantages
The primary options for treatment of soft tissue tumors include surgery with possible chemotherapy or radiation.

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

Primary Soft Tissue Tumors
The primary (intrinsic to the soft tissue) tumors can be benign or malignant. Most of the research with benign tumors had been done with desmoid tumors, which are benign but aggressive tumors that have been treated with focused ultrasound on some anecdotal cases with good results. (See “Desmoid Tumors” for more information.)

Clinical Trials Square

There are a variety of malignant soft tissue tumors including multiple types of sarcomas and other connective tissue diseases. There are clinical trials (listed below) for refractory or relapsed malignant tumors.

There has been CE approval for a company in Denmark called TOOsonix. They have treated Actinic Keratosis, Basal Cell Carcinoma, as well as other dermatologic conditions.

Secondary Soft Tissue Tumors
The secondary tumors that are found in the soft tissue most commonly come from the skin, lung, breast, kidney, colon and rectum. These malignancies are becoming the target in clinical trials, particularly in the pediatric and young adult population.

Advantages:

  • Focused ultrasound is noninvasive, so it does not carry added concerns like surgical wound healing or infection.
  • In some uses, there is an enhanced chemotherapeutic dose for the target, with less impact on the rest of the patient.
  • Focused ultrasound is radiation free.
  • It can be repeated, if necessary.

Clinical Trials

A clinical trial for pleomorphic sarcoma has begun at the University of California at San Francisco.

A clinical trial is recruiting patients with squamous cell cancer, sarcomas, or Merkle cell cancers at the University of Virginia.

A clinical trial at the Children’s National Medical Center, in Washington, D.C. is currently enrolling children and young adult patients who have a wide variety of relapsed or refractory tumors for ablative therapy. 

A clinical trial at the Children’s National Medical Center, in Washington, D.C. is currently enrolling children and young adult patients who have a wide variety of relapsed or refractory tumors for a combination of liposomal doxorubicin and focused ultrasound therapy. 

See a full list of clinical trials > 

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

Regulatory & Reimbursement

The Model JC Haifu system has received regulatory approval in Europe, Russia, and China for treatment of soft tissue tumors, including sarcomas. At present, focused ultrasound is not universally reimbursed for treatment of soft tissue sarcomas.

Patient Advocacy

Several organizations worldwide support patients with soft tissue sarcomas. Among them are:

Desmoid Tumor Research Foundation, which encourages you to join the DTRF Patient Registry in order to facilitate research efforts. With access to your experience as a patient, researchers will be able to continue learning and making new discoveries in the field of desmoid tumors. If you have ever had a desmoid tumor, you can participate. For more information, visit http://dtrf.org/.

Sarcoma Alliance, which works to improve the lives of patients affected by sarcomas through better diagnostic accuracy, improved access to care, education, and support. For more information, visit www.sarcomaalliance.org.

Sarcoma Patients Euronet, which works with clinical experts, research scientists, industry, and others to improve treatment and care for sarcoma patients in Europe by increasing awareness and providing patients with support and information. For more information, visit www.sarcoma-patients.eu.

Notable Papers

Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. Skin Res Technol. 2020 Jun 17. doi: 10.1111/srt.12883.

Mohammadabadi A, Huynh RN, Wadajkar AS, Lapidus RG, Kim AJ, Raub CB, Frenkel V. Pulsed focused ultrasound lowers interstitial fluid pressure and increases nanoparticle delivery and penetration in head and neck squamous cell carcinoma xenograft tumors. Phys Med Biol. 2020 May 27. doi: 10.1088/1361-6560/ab9705.

Cheng CS, Chen L, Xie J, Chen Z. Multimodality palliative treatment with transarterial chemoembolization and high-intensity focused ultrasound for gastric leiomyosarcoma multiple liver metastasis pain: A case report. Medicine (Baltimore). 2019 Sep;98(39):e17328. doi: 10.1097/MD.0000000000017328.

Agnese V, Costa V, Scoarughi GL, Corso C, Carina V, De Luca A, Bellavia D, Raimondi L, Pagani S, Midiri M, Stassi G, Alessandro R, Fini M, Barbato G, Giavaresi G. Focused Ultrasound Effects on Osteosarcoma Cell Lines. Biomed Res Int. 2019 May 19;2019:6082304. doi: 10.1155/2019/6082304. eCollection 2019.

Ghanouni P, Dobrotwir A, Bazzocchi A, Bucknor M, Bitton R, Rosenberg J, Telischak K, Busacca M, Ferrari S, Albisinni U, Walters S, Gold G, Ganjoo K, Napoli A, Pauly KB, Avedian R. Magnetic resonance-guided focused ultrasound treatment of extra-abdominal desmoid tumors: a retrospective multicenter study. Eur Radiol. 2017 Feb;27(2):732-740. doi: 10.1007/s00330-016-4376-5.

Shim J, Staruch RM, Koral K, Xie XJ, Chopra R, Laetsch TW. Pediatric Sarcomas Are Targetable by MR-Guided High Intensity Focused Ultrasound (MR-HIFU): Anatomical Distribution and Radiological Characteristics. Pediatr Blood Cancer. 2016 Oct;63(10):1753-60. doi: 10.1002/pbc.26079.

Avedian RS, Bitton R, Gold G, Butts-Pauly K, Ghanouni P. Is MR-guided High-intensity Focused Ultrasound a Feasible Treatment Modality for Desmoid Tumors? Clin Orthop Relat Res. 2016 Mar;474(3):697-704. doi: 10.1007/s11999-015-4364-0.

Ghanouni P, Butts Pauly K, Bitton R, Avedian R, Bucknor M,Gold G. MR guided focused ultrasound treatment of soft tissue tumors of the extremities — preliminary experience. J Ther Ultrasound. 2015; 3(Suppl 1): O69.

Click here for additional references from PubMed.

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