Functional and Ultrasound Guided Resection of Glioblastoma — FUTURE-GB  

Glioma Glioblastoma Multiforme Clinical Trial

Official title: 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.

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery.

Stage 2 will be randomised. Randomisation will be via the web-based service provided by the Oxford Clinical Trials Research Unit (OCTRU), using the method of minimisation. Participants will be randomised 1:1 to either:

1. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm)

2. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA) AND of DTI neuronavigation and NiUS (Intervention arm)

At baseline all participants will undergo a routine preoperative neuronavigation MRI scan. Those participants randomised to the experimental arm, will also have a DTI scan (additional 5 minutes in the MRI). All participants will then undergo the planned resection of their tumour, with the additional technologies if they are in the experimental arm. Following surgery, participants in both arms have the same follow up schedule and undergo standard clinical care for a total of 24 months. ;

Related Conditions & MeSH terms

• Glioblastoma
• Glioma Glioblastoma Multiforme

• NCT number: NCT05399524
• Study type: Interventional
• Source: University of Oxford
• Contact: Amy Taylor
• Phone: 44 7917 101 649
• Email: futuregb@nds.ox.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Completion date: November 2025