Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05111964

HIFU Ablation of Soft Tissue Sarcoma

Led by Oxford University Hospitals NHS Trust · Updated on 2026-02-04

10

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

O

Oxford University Hospitals NHS Trust

Lead Sponsor

S

Surgical Intervention Trials Unit, Oxford, UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

Around 3,300 people are diagnosed with soft tissue sarcoma (STS) each year in the UK, and a significant proportion of STS diagnoses are in people aged under 30 years. STS can arise from various tissue types and is comprised of over 50 tumour types. Although STS is treated with a combination of surgery, radiotherapy and chemotherapy, the prognosis is relatively poor with a five-year survival rate of 54%. There is an unmet need for further treatment modalities in STS. High intensity focused ultrasound (HIFU) is a non-invasive way of treating cancers with minimal side effects, low complication rate and quick recovery. Ultrasound waves are used to destroy tumour cells and improvements in technology and experience are enabling complete destruction of tumour. HIFU also releases tumour antigens, increasing the immune response against cancer. HIFU has received FDA approvals for several indications, including bone metastases and we are using a CE-approved HIFU device in Oxford (UKCA-approvals anticipated for 2023). There have been some publications from China showing promise in STS, however this technology needs further evaluation within the UK's healthcare setting. This study will recruit patients with both resectable and unresectable STS, in addition to unresectable small symptomatic desmoid tumours. 12-16 patients, and a minimum of 10 patients with malignant STS, will be treated over a maximum recruitment period of three years. HIFU treatment will be carried out as a day case procedure, and patients will be expected to be discharged home the same day. The study is designed to generate evidence regarding safety and feasibility of HIFU for ablation of STS and intra-abdominal desmoids. In addition, the study is anticipated to provide information about the efficacy of HIFU against these tumour types which can help in the design of later phase studies. Short-term outcomes include feasibility, safety and the completeness of destruction of the tumour. Long-term outcomes include one-year survival, local recurrence and quality of life metrics (including pain scores). The study will also look at immunological response following ablation of STS using both blood and tumour samples pre- and post-HIFU ablation.

CONDITIONS

Official Title

HIFU Ablation of Soft Tissue Sarcoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or desmoid tumours.
  • Have at least one of the following: untreated or recurrent primary resectable STS tumour 1-5cm, infield recurrent primary resectable STS tumour >1cm, primary or metastatic STS unsuitable for resection or further chemo- or radiotherapy, or small (1-8cm) symptomatic intra- or extra-abdominal desmoid tumour not indicated for surgery or declined surgery.
  • Life expectancy over 12 months and WHO performance status of 0 or 1.
  • Able to attend study visits at Churchill Hospital and Nuffield Orthopaedic Center, Oxford.
  • Willing to allow GP and Consultant to be notified of participation.
  • Able and willing to comply with study protocol and follow-up visits.
Not Eligible

You will not qualify if you...

  • Diagnosed with histologically confirmed Osteosarcoma or Chordoma.
  • Diagnosed with histologically confirmed soft tissue sarcomas: GIST, Chondrosarcoma, Kaposi's sarcoma, Ewings sarcoma, Giant cell tumour, or Angiosarcoma.
  • Active medical or psychological illness making participation unsuitable.
  • Pregnancy.
  • Ulceration, skin breakdown, or erythema over the tumour site due to tumour invasion.
  • Significant radiation skin damage over the tumour site.
  • Impractical anatomical locations for HIFU targeting: retroperitoneum, skull, neck, axilla, foot.
  • Unfavourable imaging features including tumour within 1cm of skin, interposition of gas-containing structures or ossified bone between tumour and skin, tumour margin close (<1.5cm) to major neurovascular bundles or critical visceral structures.
  • Radiotherapy within 6 months or surgery within 6 weeks to the tumour site.
  • Known allergic reactions to intravenous imaging agents used in this study.
  • Contraindications or intolerance to MRI.
  • Current involvement in phase 1 studies.
  • For soft tissue sarcoma participants: chemotherapy or investigational drug use within 30 days or 5 half-lives before intervention.
  • For desmoid participants: hormonal medication including contraceptive pill or tamoxifen, or treatment with imatinib.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Actively Recruiting

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Research Team

P

Paul C Lyon, FRCR, DPhil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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