Functional and Ultrasound Guided Resection of Glioblastoma

Last updated: May 26, 2022
Sponsor: University of Oxford
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gliomas

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT05399524
14763
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-70 years
  • Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primaryGB tumour which is maximally resectable (attempted gross total resection of allenhancing 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 nottheir first language. (Stage 2 only)
  • Able to provide a proxy who is willing to complete questionnaires as requested (Stage 2 only).

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 357
Study Start date:
November 01, 2020
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Royal Sussex County Hospital

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • Southmead Hospital, North Bristol NHST

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Addenbrookes Hospital, Cambridge University NHSFT

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales, Cardiff & Vale University Health Board

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • University Hospital, Coventry

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Ninewells Hospital, NHS Tayside

    Dundee, DD2 1SG
    United Kingdom

    Active - Recruiting

  • The Royal Infirmary of Edinburgh, NHS Lothian

    Edinburgh, EH16
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • The Walton Centre

    Liverpool, L9 7LJ
    United Kingdom

    Active - Recruiting

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

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Royal London Hospital, Barts Health NHS Trust

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • James Cook University Hospital, South Tees Hospitals NHSFT

    Middlesbrough, TS4 3BW
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Queen's Medical Centre, Nottingham University Hospitals NHST

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • The John Radcliffe Hospital, Oxford University Hospitals NHSFT

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • Derriford Hospital, University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

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

    Romford, RM7 0AG
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Southampton General Hospital, University Hospital Southampton NHSFT

    Southampton,
    United Kingdom

    Active - Recruiting

  • Royal Stoke University Hospital, University Hospitals of North Midlands NHST

    Stoke-on-Trent, ST4 6QG
    United Kingdom

    Active - Recruiting

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