Non-invasive treatment for soft tissue sarcoma using focused ultrasound

A Pilot Study in High Intensity Focused Ultrasound Ablation of Soft Tissue Sarcoma and Small Symptomatic Desmoid Tumours

This study is testing a new non-invasive ultrasound treatment for people with soft tissue sarcomas to see if it can safely shrink their tumors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Oxford University Hospitals NHS Trust (other)
• Drugs / interventions: imatinib, chemotherapy, radiation
• Locations: 1 site (Oxford, Oxfordshire)
• Trial ID: NCT05111964 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of High Intensity Focused Ultrasound (HIFU) to treat soft tissue sarcomas, a rare but serious type of cancer. The study aims to evaluate the safety, feasibility, and efficacy of HIFU in patients with histologically-confirmed, targetable soft tissue sarcomas, particularly those with tumors sized between 1-5 cm. Participants will undergo HIFU ablation, along with tumor biopsies and blood tests, to assess the immune response and tumor destruction. The trial is conducted at the Oxford Bone and Soft Tissue Tumour Service, a specialized center for sarcoma treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically-confirmed, HIFU-targetable soft tissue sarcomas measuring 1-5 cm.

Not a fit: Patients with non-resectable tumors or those with larger tumors (>5 cm) may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive treatment option with fewer side effects and quicker recovery for patients with soft tissue sarcoma.

How similar studies have performed: While HIFU has shown promise in treating other cancer types, its application in soft tissue sarcoma is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

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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:

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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.

Where this trial is running

Oxford, Oxfordshire

• Churchill Hospital — Oxford, Oxfordshire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Paul C Lyon, FRCR, DPhil — Oxford University Hospitals NHS Trust
• Study coordinator: Paul C Lyon, FRCR, DPhil

Conditions: Soft Tissue Sarcoma, Desmoid Tumors, HIFU, Focused Ultrasound, Immunology