10
Participants
Start Date
December 10, 2021
Primary Completion Date
December 10, 2025
Study Completion Date
December 10, 2026
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."
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."
RECRUITING
Churchill Hospital, Oxford
Surgical Intervention Trials Unit, Oxford, UK
UNKNOWN
National Institute for Health Research, United Kingdom
OTHER_GOV
Oxford Radiology Research Unit, Churchill Hospital, Oxford, UK
UNKNOWN
Oxford University Hospitals NHS Trust
OTHER