Sound waves vs. tumors: new ultrasound treatment tested for sarcoma
NCT ID NCT05111964
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing whether high-intensity focused ultrasound (HIFU) can safely destroy soft tissue sarcoma and small desmoid tumors without surgery. About 10-16 adults with these tumors will receive a single outpatient treatment using a CE-approved device. The goal is to see if the procedure is feasible and safe, and to gather early data on how well it works, including tumor destruction and immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High intensity focused ultrasound (HIFU) device
- What this could lead to
- If successful, this could offer a non-invasive, outpatient treatment option for soft tissue sarcoma and desmoid tumors, potentially reducing the need for surgery or radiation.
- What could go wrong
- This is a very small pilot study (10-16 patients) focused on safety and feasibility, not effectiveness. The technology is still experimental for these tumors, and risks include incomplete tumor destruction or complications requiring surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \-------- The participant is eligible for the study if they are: Willing and able to give informed consent for participation in the study. Aged 18 years or above. Diagnosed with histologically-confirmed and HIFU-targetable soft tissue sarcoma of several subtypes, including but not necessarily limited to: * Malignant fibrous histiocytoma * Undifferentiated (pleomorphic) sarcoma * Fibrosarcoma and fibromyxoid sarcoma (fibroblastic sarcomas) * Leiomyosarcoma * Liposarcoma * Malignant peripheral nerve sheath tumour * Retroperitoneal sarcoma * Rhabdomyosarcoma * Synovial sarcoma * Sacral chordoma (following amendment) * Desmoid tumours (intra- or extra-abdominal, following amendment) Have at least one of the following: * Untreated or recurrent primary resectable STS tumour 1-5cm diameter, targetable by HIFU * Infield recurrent primary resectable STS tumour of \>1cm diameter, targetable by HIFU * Primary or metastatic STS unsuitable for resection or further chemo- or radiotherapy, targetable by HIFU * Small (1-8cm) symptomatic intra- or extra-abdominal desmoid tumour, targetable by HIFU, which is not indicated for surgery (or patient has declined surgery) Have life expectancy of over 12 months and a World Health Organisation (WHO) performance status of less than or equal to 1. Be able to attend Churchill Hospital and Nuffield Orthopaedic Center, Oxford, potentially for multiple visits, and thus be based in the UK. Willing to allow his or her GP and Consultant to be notified of participation in the study. Able and willing to give written informed consent, indicating that they are aware of the investigational nature of this study and potential risks, and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations. Exclusion Criteria: \-------- The participant may not enter the study if ANY of the following apply: Diagnosed with histologically confirmed Osteosarcoma or Chordoma Diagnosed with histologically confirmed soft tissue sarcoma of the following subtypes: * GIST * Chondrosarcoma * Kaposi's sarcoma * Ewings sarcoma * Giant cell tumour * Angiosarcoma Active medical or psychological illness that would render the patient unsuitable for the interventions required for the study (exclusion at the discretion of the investigator). Pregnancy. Ulceration / skin breakdown / erythema overlying the target tumour site due to tumour invasion (exclusion at the discretion of the investigator). Significant radiation skin damage overlying the target tumour site (exclusion at the discretion of the investigator). Impractical anatomical locations for HIFU targeting (using JC200 treatment device) (exclusion at the discretion of the investigator): * Retroperitoneum * Skull * Neck * Axilla * Foot Unfavourable imaging features on previously acquired cross-sectional imaging, including: * Tumour within 1cm of the skin surface * Interposition (or close proximity) of a gas-containing structure between tumour and skin such as fixed (retroperitoneal) bowel or lung * Interposition of a continuous ossified bone between tumour and skin, such as coverage by pelvis or scapula * Tumour margin close (\<1.5cm) or encasing major neurovascular bundles (such as the sciatic nerve) * Tumour margin close (\<1.5 cm) to critical visceral structures (e.g. bladder or bowel) Recent radiotherapy (under 6 months) to the target tumour site. Recent surgery (under 6 weeks) to the target tumour site. Have any known allergic reactions to intravenous imaging agents to be used in this study (exclusion at the discretion of the investigator). Have contraindication(s) or intolerance to MRI (exclusion at the discretion of the investigator). Current involvement in phase 1 studies. Soft tissue sarcoma participants: Use of chemotherapy or of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the intervention. Desmoid participants: hormonal medication including the contraceptive pill or tamoxifen, or being treated with imatinib.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Churchill Hospital
RECRUITINGOxford, Oxfordshire, United Kingdom
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