Functional and Ultrasound Guided Resection of Glioblastoma

NCT05399524 | Unknown DMC

• 1 other identifier: 14763
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 24

Brief 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

Conditions

Glioma Glioblastoma Multiforme

Keywords

DTI; iUS

Outcome Measures

Primary Outcomes (2)

• Stage 1 Primary Outcome: to demonstrate the feasibility of using DTI and iUS in addition to standard of care for neurosurgery using a combination of qualitative and quantitative data to prove workflow capability at each site.

  Sites are qualitatively assessed through a standardisation stage, providing feedback to enable learning and ensure the workflow is followed. Sites with satisfactory data will "progress" and pass into Stage 2. The measures assessed in combination are: 1. Operation length, in normal range for this surgery. 2. Use of DTI neuronavigation \& iUS to achieve maximal safe tumour resection without major neurological deficit, measured by getting clear, relevant images for the DTI \& US scans, and accurate pre-operative tractography. 3. Extent of tumour resection (cm³ remaining) on postoperative MRI scan. 4. Surgical Complications/Serious Adverse Events-measured from recorded post-operative complications and a 6-month notes check to ensure patient safety. If the assessment panel is satisfied with the data after \~3 recruits, a site will progress into Stage 2 of the trial, the RCT. Data will be analysed for Stage 1 once all sites have progressed through into Stage 2 of the trial.

  Measured 6 weeks post-surgery

• Stage 2 Primary Outcome: to assess whether additional imaging to standard of care changes Deterioration Free Survival (DFS) (Where deterioration relates to global health status only)

  This is measured by a composite of: 1. Change in global health status domain of the QLQ-C30 questionnaire (Quality of Life Questionnaire Cancer) from baseline to final questionnaire completion. Questionnaires are administered at baseline, 6 weeks, then every 3 months until 24months. 2. Progression Free Survival (PFS). This is measured by radiological tumour progression on imaging, which is taken 3-months post-op and 3-monthly thereafter. 3. Overall Survival (OS) with an event defined as either deterioration, progression or death.

  Measured from baseline up to 24 months

Secondary Outcomes (9)

• Stage 2: To assess if additional intraoperative imaging changes DFS where deterioration relates to physical and social functioning, and motor and communication dysfunction

  Measured from baseline up to 24 months

• Stage 2: To assess whether additional intraoperative imaging to standard of care changes time to deterioration

  Measured from baseline up to 24 months

• Stage 2: To assess whether additional intraoperative imaging to standard of care improves Overall Survival (OS)

  To be recorded at 24 months

• Stage 2: To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) changes Progression Free Survival (PFS)

  MRI at 6 months post-op., and then 3 monthly up to 24 months or an MRI performed outside protocol if patient is symptomatic

• Stage 2: To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) changes the extent of tumour resection

  Measured 1 week post-surgery

Other Outcomes (2)

• Tertiary Mechanistic Objectives (on a sub set of participants): assessment of the sensitivity and specificity of the anatomico-spatial location of DTI fibre tracts compared to Standard of Care

  6 weeks post-surgery

• Tertiary Mechanistic Objectives (on a sub set of participants): assessment of the sensitivity and specificity of iUS to identify the tumour boundary when compared with 5-ALA.

  6 weeks post-surgery

Study Arms (2)

Additional pre- and intra-operative imaging

EXPERIMENTAL

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))

Other: Additional pre- and intra-operative imaging

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Standard of Care OTHER

Neuronavigation and intraoperative 5-ALA

Standard of Care

Additional pre- and intra-operative imaging 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)

Also known as: DTI, IUS

Additional pre- and intra-operative imaging

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Midline/basal ganglia/cerebellum/brainstem GB
• Multifocal GB
• Recurrent GB
• Suspected secondary GB
• Contraindication to MRI

Sponsors & Collaborators

• University of Oxford: lead
• Imperial College Healthcare NHS Trust: collaborator
• Efficacy and Mechanism Evaluation (EME) Programme: collaborator

Study Sites (24)

Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT

Birmingham, B15 2TH, United Kingdom

NOT YET RECRUITING

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

NOT YET RECRUITING

Southmead Hospital, North Bristol NHST

Bristol, BS10 5NB, United Kingdom

RECRUITING

Addenbrookes Hospital, Cambridge University NHSFT

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

University Hospital of Wales, Cardiff & Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

RECRUITING

University Hospital, Coventry

Coventry, CV2 2DX, United Kingdom

NOT YET RECRUITING

Ninewells Hospital, NHS Tayside

Dundee, DD2 1SG, United Kingdom

RECRUITING

The Royal Infirmary of Edinburgh, NHS Lothian

Edinburgh, EH16, United Kingdom

RECRUITING

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

RECRUITING

The Walton Centre

Liverpool, L9 7LJ, United Kingdom

RECRUITING

Royal London Hospital, Barts Health NHS Trust

London, E1 1BB, United Kingdom

RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Charing Cross Hospital/St Mary's, Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

RECRUITING

James Cook University Hospital, South Tees Hospitals NHSFT

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT

Newcastle upon Tyne, NE1 4LP, United Kingdom

NOT YET RECRUITING

Queen's Medical Centre, Nottingham University Hospitals NHST

Nottingham, NG7 2UH, United Kingdom

RECRUITING

The John Radcliffe Hospital, Oxford University Hospitals NHSFT

Oxford, OX3 9DU, United Kingdom

RECRUITING

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT

Preston, PR2 9HT, United Kingdom

NOT YET RECRUITING

Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHST

Romford, RM7 0AG, United Kingdom

NOT YET RECRUITING

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

NOT YET RECRUITING

Southampton General Hospital, University Hospital Southampton NHSFT

Southampton, United Kingdom

RECRUITING

Royal Stoke University Hospital, University Hospitals of North Midlands NHST

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Puneet Plaha

  University of Oxford

  STUDY DIRECTOR

Central Study Contacts

Amy Taylor

CONTACT

44 7917 101 649; futuregb@nds.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: June 1, 2022
• Study Start: November 1, 2020
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 1, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (24)