Functional and Ultrasound Guided Resection of Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2025-11-30

Brief Summary

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

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Detailed Description

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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

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Glioma Glioblastoma Multiforme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

FUTURE-GB is a 2-Stage trial: Stage 1 is a non-randomised multicentre learning and evaluation Stage (IDEAL IIB study), and Stage 2 a prospective, multicentre definitive randomised controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants are blinded

Study Groups

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Additional pre- and intra-operative imaging

Surgery to resect the GB using Diffusion Tensor Imaging (DTI) and intraoperative Ultrasound (iUS) (navigated iUS where available) in addition to standard care (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-aminolevulinic acid (5-ALA))

Group Type EXPERIMENTAL

Additional pre- and intra-operative imaging

Intervention Type OTHER

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)

Standard of Care

The comparator is standard care as per current NICE guidelines (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-ALA).

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Neuronavigation and intraoperative 5-ALA

Interventions

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Standard of Care

Neuronavigation and intraoperative 5-ALA

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

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DTI IUS

Eligibility Criteria

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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).