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.

Trial ID: NCT05399524

Interventional - Phase Unknown - Unknown status

Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours

Conditions

• Glioma Glioblastoma Multiforme

Interventions

• Standard of Care
• Additional pre- and intra-operative imaging

Eligibility

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

Sponsor

University of Oxford, Imperial College Healthcare NHS Trust, Efficacy and Mechanism Evaluation (EME) Programme

Source: ClinicalTrials.gov

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