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Soft Tissue Tumors

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites. There are also clinical trials that may be of interest to patients.

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 soft tissue tumors. Some soft tissue tumors have had significant progress in their development, and thus had their own listing. See Basal Cell Carcinoma, Actinic Keratosis, Sarcoma- (both osteo and non-osteo types). 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. The Toosonix device is specifically designed to help with very superficial tumors. 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.)

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 in Europe 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 basal cell carcinoma has begun in Denmark.

A clinical trial for sarcoma has begun in Oxford, UK.

A clinical trial for a number of recurrent solid tumors has begun recruiting patients at Children’s National in Washington, DC.  

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 >

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

Kim J, Kim J, Lee DK, Shin EJ, Chang JH. High-Intensity focused ultrasound linear array and system for dermatology treatment. Ultrasonics. 2025 Jan;145:107477. doi: 10.1016/j.ultras.2024.107477. Epub 2024 Sep 19. PMID: 39332247 

Calik J, Zawada T, Sauer N, Bove T. High Intensity Focused Ultrasound (20 MHz) and Cryotherapy as Therapeutic Options for Granuloma Annulare and Other Inflammatory Skin Conditions. Dermatol Ther (Heidelb). 2024 May;14(5):1189-1210. doi: 10.1007/s13555-024-01163-7. Epub 2024 May 4. PMID: 38703308 

Long Z, Hesley GK, Lu A, Hangiandreou NJ, Gorny KR, Tiegs-Heiden CA. MRgFUS ablation of a recurrent tenosynovial giant cell tumor in the foot using ExAblate 2100 system in combination with patient immobilization device. Radiography (Lond). 2024 Apr 3;30(3):840-842. doi: 10.1016/j.radi.2024.03.010. PMID: 38574580 

Laganà AS, Romano A, Vanhie A, Bafort C, Götte M, Aaltonen LA, Mas A, De Bruyn C, Van den Bosch T, Coosemans A, Guerriero S, Haimovich S, Tanos V, Bongers M, Barra F, Al-Hendy A, Chiantera V, Leone Roberti Maggiore U. Management of Uterine Fibroids and Sarcomas: the Palermo Position Paper. Gynecol Obstet Invest. 2024 Feb 21. doi: 10.1159/000537730. PMID: 38382486 

Click here for more references from PubMed.