NCT05399524

Functional and Ultrasound Guided Resection of Glioblastoma

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Glioma Glioblastoma Multiforme

Interventions

Type	Name	Description
OTHER	Standard of Care	Neuronavigation and intraoperative 5-ALA
OTHER	Additional pre- and intra-operative imaging	Additional DTI scan during routine pre-operative tumour MRI scan, additional use of intraoperative ultrasound in addition to normal to standard of care (Neuronavigation and intraoperative 5-ALA)

Timeline

• Start date: 2020-11-01
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2022-06-01
• Last updated: 2022-06-01

Locations

24 sites across 1 country: United Kingdom