The FUTURE-GB study is a 2-stage NIHR EME Funded Portfolio trial aiming to assess if the use of extra intra-operative imaging technology - Diffusion Tensor Imaging (DTI) and Ultrasound (US) - in addition to standard of care during surgical resection can increase deterioration-free survival (DFS) in patients with newly diagnosed glioblastoma.
It is aimed for the trial to be open at Neurosurgery hospitals across the UK where glioblastoma surgery is undertaken.
- Stage 1 is an IDEAL Stage 2b non-randomised cohort, evaluating standard care surgery with the addition of DTI and US imaging during the operation, to inform quality of delivery and standardisation of practices for Stage 2. This stage aims to recruit approximately 3 patients per site in order to ensure sites have a standardised procedure for taking and uploading the images needed for Stage 2.
- Stage 2 is a prospective, multicentre definitive randomised controlled trial aiming to recruit 357 patients over 27 months, randomising patients to standard care or to the additional imaging intervention. This Stage has 2 mechanistic sub-studies.
What is the difference between Stage 1 and Stage 2?
Stage 1 is an IDEAL evaluation, aiming to understand how clinicians use the imaging technologies (DTI and US) during surgery as per study protocol. A standardisation and harmonisation phase, Stage 1 will run initially at each site until they recruit approximately 3 participants and have finalised their workflow and imaging uploads sufficiently. This part involves no randomisation and all patients recruited to this stage will have DTI and iUS during surgery. There is no change to the clinical or surgical practice other than the taking of additional images pre and intra-operatively.
Stage 2 follows directly on from Stage 1 as a progression, and is the main RCT to answer the trial hypothesis – this stage will include randomisation and the follow-up of patients out to 24 months. Participants will be recruited, with a partner/spouse/friend as a proxy, and Quality of Life and function measurements taken at baseline, surgery, hospital discharge and every 3 months up to 24 months post randomisation. The imaging schedule will follow standard of care up to 24 months post randomisation.
Note - Recruitment of a patient to the trial, will not change any post-surgical treatment pathways.
Downloading Study Documents
Key study documents for both Stage 1 and Stage 2 such as the Protocol and Patient Information Sheets can be downloaded from SIMS, the links for which are below: