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

University of Oxford

Status: Enrolling

Conditions: Glioma Glioblastoma Multiforme

Treatments: Other: Standard of Care; Other: Additional pre- and intra-operative imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05399524

14763

Details and patient eligibility

About

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

Full 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.

Enrollment: 357 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

357 participants in 2 patient groups

Additional pre- and intra-operative imaging

Experimental group

Description:

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))

Treatment:

Other: Additional pre- and intra-operative imaging

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care