Spots Global Cancer Trial Database for Functional and Ultrasound Guided Resection of Glioblastoma
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Trial Identification
Brief Title: Functional and Ultrasound Guided Resection of Glioblastoma
Official Title: FUTURE-GB Trial (Functional and Ultrasound-guided Resection of Glioblastoma) A 2-Stage Trial. A Learning Phase Evaluation of Participating Centres, Followed by a Randomised, Controlled Multicentre Phase III Trial.
Study ID: NCT05399524
Conditions
Study Description
Brief Summary: Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours
Detailed Description: Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery. Stage 2 will be randomised. Randomisation will be via the web-based service provided by the Oxford Clinical Trials Research Unit (OCTRU), using the method of minimisation. Participants will be randomised 1:1 to either: 1. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm) 2. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA) AND of DTI neuronavigation and NiUS (Intervention arm) At baseline all participants will undergo a routine preoperative neuronavigation MRI scan. Those participants randomised to the experimental arm, will also have a DTI scan (additional 5 minutes in the MRI). All participants will then undergo the planned resection of their tumour, with the additional technologies if they are in the experimental arm. Following surgery, participants in both arms have the same follow up schedule and undergo standard clinical care for a total of 24 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT, Birmingham, , United Kingdom
Royal Sussex County Hospital, Brighton, , United Kingdom
Southmead Hospital, North Bristol NHST, Bristol, , United Kingdom
Addenbrookes Hospital, Cambridge University NHSFT, Cambridge, , United Kingdom
University Hospital of Wales, Cardiff & Vale University Health Board, Cardiff, , United Kingdom
University Hospital, Coventry, Coventry, , United Kingdom
Ninewells Hospital, NHS Tayside, Dundee, , United Kingdom
The Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, , United Kingdom
Hull Royal Infirmary, Hull, , United Kingdom
Leeds General Infirmary, Leeds, , United Kingdom
The Walton Centre, Liverpool, , United Kingdom
Royal London Hospital, Barts Health NHS Trust, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Charing Cross Hospital/St Mary's, Imperial College Healthcare NHS Trust, London, , United Kingdom
James Cook University Hospital, South Tees Hospitals NHSFT, Middlesbrough, , United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT, Newcastle Upon Tyne, , United Kingdom
Queen's Medical Centre, Nottingham University Hospitals NHST, Nottingham, , United Kingdom
The John Radcliffe Hospital, Oxford University Hospitals NHSFT, Oxford, , United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, , United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT, Preston, , United Kingdom
Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHST, Romford, , United Kingdom
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
Southampton General Hospital, University Hospital Southampton NHSFT, Southampton, , United Kingdom
Royal Stoke University Hospital, University Hospitals of North Midlands NHST, Stoke-on-Trent, , United Kingdom
Contact Details
Name: Puneet Plaha
Affiliation: University of Oxford
Role: STUDY_DIRECTOR
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