Background

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 up to 75 patients over 6-9 months.
 
  • 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.