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 2 is a prospective, multicentre definitive randomised controlled trial aiming to recruit 357 patients over 27 months, randomising patients to standard care. 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. This Stage is for 6-9 months and sites will recruit 5-10 particpants per site. This part involves no randomisation and all patients recruited to this stage will have DTI and iUS during surgery.
Stage 2 follows directly on from Stage 1 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 an 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.