HIFU Ablation of Soft Tissue Sarcoma

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 10, 2021

Primary Completion Date

December 10, 2025

Study Completion Date

December 10, 2026

Conditions
Soft Tissue SarcomaDesmoid; Abdominal
Interventions
DEVICE

High Intensity Focused Ultrasound Ablation

"The focused ultrasound exposure will be performed using the Haifu® Model-JC200 Focused Ultrasound Tumour Therapeutic System at the Churchill Hospital site, CE-approved for tumour therapy (or subsequent CE-approved device upgrades by Haifu®). The participant will be positioned over the therapeutic device and water bath used to transmit the focused ultrasound to the target tumour. No anaesthesia or any combination of local anaesthesia, nerve block, epidural, conscious sedation or general anaesthetic may be used, depending on anatomical location, size of tumour, preference of HIFU team, patient and anaesthetist and other patient factors.~In therapy mode, the tumour volume is treated with focused ultrasound to ablate the tumour tissues to high temperatures (in excess of 60ºC) using focused ultrasound targeted from outside the body.~Patients are typically discharged with 24 hours."

DIAGNOSTIC_TEST

Tumour Biopsy and Venous Blood Tests

"Where appropriate, participants are also encouraged to undergo a pre-HIFU (and in the case of unresectable STS, post-HIFU) ultrasound biopsy of the target tumour and additional blood tests to inform the immunological aspects of the study. Having the biopsy does not mandate enrolment on the trial, and patients will be free to leave the trial at any stage. The pre-HIFU (and post-HIFU) biopsies are altruistically encouraged but not absolutely essential to enrolment on the trial.~Biopsies will be performed under ultrasound guidance by an experienced radiologist using local anaesthetic."

Trial Locations (1)

Unknown

RECRUITING

Churchill Hospital, Oxford

All Listed Sponsors
collaborator

Surgical Intervention Trials Unit, Oxford, UK

UNKNOWN

collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

collaborator

Oxford Radiology Research Unit, Churchill Hospital, Oxford, UK

UNKNOWN

lead

Oxford University Hospitals NHS Trust

OTHER