Functional and Ultrasound Guided Resection of Glioblastoma (FUTURE-GB)

  • STATUS
    Recruiting
  • End date
    Nov 18, 2025
  • participants needed
    357
  • sponsor
    University of Oxford
Updated on 18 June 2022

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

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.

Details
Condition Glioma Glioblastoma Multiforme
Treatment Standard of Care, Additional pre- and intra-operative imaging
Clinical Study IdentifierNCT05399524
SponsorUniversity of Oxford
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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