FUT U RE – GB Trial (Functional and Ultrasound guided Resection of Glioblastoma) A 2-Stage trial. Stage 1 Non-randomised learning phase evaluation of participating centres (an IDEAL study), followed by Stage 2 which is randomised,controlled Multicentre Phase III trial with 2 mechanistic substudies
Surgeons are testing whether two additional imaging tools, used during brain tumour surgery, can give patients more time before their condition worsens. Glioblastoma is the most common and aggressive form of brain cancer, and it is incurable. Surgery to remove as much of the tumour as possible improves survival, but it carries a risk of damaging healthy brain tissue, which can leave patients with lasting disabilities. Currently, surgeons rely on preoperative MRI scans and a fluorescent dye that makes tumour cells glow. This trial adds two technologies: Diffusion Tensor Imaging (DTI), which maps critical nerve fibre tracts in the brain, and navigated intraoperative ultrasound (NiUS), which helps identify tumour boundaries in real time. The goal is to remove more tumour while avoiding damage to essential brain functions. The trial will recruit 357 newly diagnosed patients across UK neurosurgical centres. Half will receive standard surgery; the other half will also have DTI and NiUS guidance. Patients and assessors will not know which group they are in. The researchers will track deterioration-free survival, overall survival, quality of life, and complication rates over 24 months. If the techniques prove effective, they could become standard practice across all 24 adult neurosurgical units in the NHS, offering patients longer survival without functional decline.
View original technical description
RESEARCH QUESTION: During glioblastoma (GB) tumour resection, does the addition of the intraoperative technologies Diffusion Tensor Imaging (DTI) and Navigated intraoperative UltraSound (NiUS), to standard care (neuronavigation based on preoperative MRI and intraoperative use of 5-aminolevulinic acid, 5-ALA), improve Deterioration Free Survival (DFS)? BACKGROUND: GB is incurable and the most frequent and aggressive form of brain cancer, with an extremely poor prognosis. Patients experience a decline in health-related quality of life (HRQoL), and caregivers report high levels of distress and carer burden. Surgery is the most effective treatment and maximal surgical resection improves survival, but carries a potential risk of morbidity. AIMS AND OBJECTIVES: The aim of FUTURE-GB is to evaluate whether the use of DTI and NiUS, in addition to standard intraoperative tools, during GB tumour resection, improves DFS. The research objectives are to assess the patient impact of using these supplementary surgical technologies during GB resection, with reference to DFS, overall and progression free survival, extent of tumour resection, surgical complications/adverse events, number of patients eligible for adjuvant therapy following surgery, and functional outcome (cognitive/physical/performance status) post surgery. In addition, there are two mechanistic components which asses the sensitivity and specificity of the anatomical location of fibre tracts on preoperative DTI compared with intraoperative direct electrical stimulation in patients undergoing awake surgery, and, NiUS to identify the tumour boundary when compared with 5-ALA. METHODS: Future-GB is a two stage trial. Stage 1 is a non-randomised multicentre learning and evaluation phase (IDEAL Phase 2B study), and Stage 2 a prospective, phase III, multicentre randomised controlled trial. It aims to recruit 357 newly diagnosed GB patients to receive either standard techniques during surgery, or surgery that uses NiUS and DTI as well. Patients and assessors will be blinded to study arm. The trial will result in only minor changes to the present care pathway for patients with a suspected GB. Participating patients will complete HRQoL questionnaires (EORTC QLQ-C30 and BN20), and undergo a brief preoperative physical (Barthel Index and MRC power grading in all 4 limbs) and functional/cognitive assessments (WHO performance status and Montreal Cognitive Assessment, MOCA). These measures will be repeated postoperatively (prior to discharge), and at regular intervals over the following 24 months, combined with planned hospital visits. The mortality of participants, and any complications will also be recorded. TIMELINES FOR DELIVERY: The study duration is 60 months, commencing in September, 2019. Months 1-9 comprise the IDEAL IIb. Recruitment will continue until month 33. In months 10 to 51, follow-up will be completed, and months 55 to 60 are reserved for the analysis and final report. ANTICIPATED IMPACT AND DISSEMINATION: It is anticipated that the two additional surgical techniques will prolong DFS. Increased survival without functional compromise has obvious benefit for patients and relatives, substantial health gains for society, and significant economic implications. Proven intraoperative techniques would be applied as standard care across the NHS, in all 24 adult UK neurosurgical trusts. In addition, such surgical technologies have clear global appeal and worldwide impact
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know