FUTURE GB
Research type
Research Study
Full title
Functional and Ultrasound guided Resection of Glioblastoma. A two stage trial. Stage 1 – Non-randomised collaborative learning and evaluation phase of participating centres (IDEAL Stage 2b study), followed by Stage 2 – A Multicentre Phase III trial with 2 mechanistic substudies.
IRAS ID
264482
Contact name
Puneet Plaha
Contact email
Sponsor organisation
Clinical Trials & Research Governance, University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This project asks: What is the best technology a surgeon can use to remove as much brain cancer as possible, whilst minimising risk of damage to brain function and improving patient quality of life?
For patients with a brain tumour called Glioblastoma (GB) prolonging survival whilst ensuring quality of life are key, but remain challenging. GB is incurable and the most frequent and aggressive form of brain cancer, with an extremely poor prognosis both in quality and length of life.
Patients experience a decline in Health-Related Quality of Life (HRQoL), and caregivers report high levels of distress and carer burden. The main treatments for GB are surgery, radiotherapy, and chemotherapy, used in various combinations. For patients where it is thought that surgery will benefit, a surgeon often removes as much as possible, whilst limiting the risk of causing problems, such as, weakness, speech or cognitive difficulties. However, it is unclear as to which techniques a surgeon should use to remove the tumour safely. This influences when the cancer returns, what symptoms the patient has, and how a patient feels.
Ultrasound (US) (high frequency sound waves which create an image) is one of the tools a surgeon can use during the operation to find the tumour and assess how much is being removed during the operation. Another technique, Diffusion Tensor Imaging (DTI) allows important fibres involved in specific functions, for example, speech/language, vision, and movement to be seen during surgery. This means that potential damage to these functions might be avoided during the procedure.
This study aims to see if surgery to remove a GB with additional imaging added to present standard techniques improves HRQoL. This will be assessed through participants and their proxies completing HRQoL questionnaires before and after surgery for up to 2 years.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0840
Date of REC Opinion
16 Sep 2020
REC opinion
Further Information Favourable Opinion