Improving surgery for glioblastoma using advanced imaging techniques
FUTURE-GB Trial (Functional and Ultrasound-guided Resection of Glioblastoma) A 2-Stage Trial. A Learning Phase Evaluation of Participating Centres, Followed by a Randomised, Controlled Multicentre Phase III Trial.
NA · University of Oxford · NCT05399524
This study is testing if using advanced imaging techniques during surgery can help people with glioblastoma have better outcomes compared to standard surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 357 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Oxford (other) |
| Drugs / interventions | chemotherapy |
| Locations | 24 sites (Birmingham and 23 other locations) |
| Trial ID | NCT05399524 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of functional and ultrasound-guided resection techniques for glioblastoma. In the first stage, all participants will receive advanced imaging technologies during surgery, while the second stage will involve a randomized comparison between standard care and enhanced imaging techniques. Participants will undergo preoperative MRI scans, and those in the experimental group will receive additional diffusion tensor imaging (DTI) scans. The study will follow participants for 24 months post-surgery to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a primary glioblastoma tumor deemed maximally resectable by a neuro-oncology team.
Not a fit: Patients with midline, basal ganglia, cerebellum, brainstem glioblastomas, or those with recurrent or multifocal tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and survival rates for patients with glioblastoma.
How similar studies have performed: Other studies have shown promising results with advanced imaging techniques in neurosurgery, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years * Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour) * Patient is suitable for concomitant adjuvant radiotherapy and Temozolomide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision * Able to receive 5-ALA * Willing and able to give informed consent * Able to complete trial questionnaires, this may be with support where English is not their first language. (Stage 2 only) * Able to provide a proxy who is willing to complete questionnaires as requested (Stage 2 only). Exclusion Criteria: * Midline/basal ganglia/cerebellum/brainstem GB * Multifocal GB * Recurrent GB * Suspected secondary GB * Contraindication to MRI
Where this trial is running
Birmingham and 23 other locations
- Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT — Birmingham, United Kingdom (NOT_YET_RECRUITING)
- Royal Sussex County Hospital — Brighton, United Kingdom (NOT_YET_RECRUITING)
- Southmead Hospital, North Bristol NHST — Bristol, United Kingdom (RECRUITING)
- Addenbrookes Hospital, Cambridge University NHSFT — Cambridge, United Kingdom (RECRUITING)
- University Hospital of Wales, Cardiff & Vale University Health Board — Cardiff, United Kingdom (RECRUITING)
- University Hospital, Coventry — Coventry, United Kingdom (NOT_YET_RECRUITING)
- Ninewells Hospital, NHS Tayside — Dundee, United Kingdom (RECRUITING)
- The Royal Infirmary of Edinburgh, NHS Lothian — Edinburgh, United Kingdom (RECRUITING)
- Hull Royal Infirmary — Hull, United Kingdom (RECRUITING)
- Leeds General Infirmary — Leeds, United Kingdom (RECRUITING)
- The Walton Centre — Liverpool, United Kingdom (RECRUITING)
- Royal London Hospital, Barts Health NHS Trust — London, United Kingdom (RECRUITING)
- King's College Hospital — London, United Kingdom (RECRUITING)
- Charing Cross Hospital/St Mary's, Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)
- James Cook University Hospital, South Tees Hospitals NHSFT — Middlesbrough, United Kingdom (RECRUITING)
- Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT — Newcastle Upon Tyne, United Kingdom (NOT_YET_RECRUITING)
- Queen's Medical Centre, Nottingham University Hospitals NHST — Nottingham, United Kingdom (RECRUITING)
- The John Radcliffe Hospital, Oxford University Hospitals NHSFT — Oxford, United Kingdom (RECRUITING)
- Derriford Hospital, University Hospitals Plymouth NHS Trust — Plymouth, United Kingdom (RECRUITING)
- Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT — Preston, United Kingdom (NOT_YET_RECRUITING)
- Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHST — Romford, United Kingdom (NOT_YET_RECRUITING)
- Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (NOT_YET_RECRUITING)
- Southampton General Hospital, University Hospital Southampton NHSFT — Southampton, United Kingdom (RECRUITING)
- Royal Stoke University Hospital, University Hospitals of North Midlands NHST — Stoke-on-Trent, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Amy Taylor
- Email: futuregb@nds.ox.ac.uk
- Phone: 44 7917 101 649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioma Glioblastoma Multiforme, DTI, iUS