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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| Efficacy and Mechanism Evaluation (EME) Programme | OTHER |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)) |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Neuronavigation and intraoperative 5-ALA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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:
| Measured from baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 2: To assess if additional intraoperative imaging changes DFS where deterioration relates to physical and social functioning, and motor and communication dysfunction | This is measured using a combination of specific questions (physical functioning and social functioning) in the QLQ-C30 (Quality of Life Questionnaire Cancer) and BN20 questionnaire (Quality of Life Questionnaire Brain) (motor dysfunction and communication deficit questions), combined with the values of Progression Free Survival (PFS) and overall survival (OS) taken from the primary outcome. Questionnaires are administered at baseline, 6 weeks, then every 3 months until 24months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To assess the sensitivity and specificity of the anatomico-spatial location of DTI fibre tracts compared with intraoperative direct electrical stimulation/behavioural change without stimulation but related to adjacent white fibre tract in patients undergoing awake surgery, or motor evoked potential changes in patients undergoing surgery. Measured by sensitivity and specificity calculation using pre and post-surgery MRI images |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Taylor | Contact | 44 7917 101 649 | futuregb@nds.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Puneet Plaha | University of Oxford | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT | Not yet recruiting | Birmingham | B15 2TH | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2022 | Apr 27, 2022 |
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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.
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Participants are blinded
| 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) |
|
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| Measured from baseline up to 24 months |
| Stage 2: To assess whether additional intraoperative imaging to standard of care changes time to deterioration | Defined similar to DFS with the exception that progression is excluded as an event (i.e. only deterioration or death are considered). There will be five time to deterioration outcomes, one for each of the domains utilised in the primary and secondary DFS outcomes, used in turn to define deterioration | Measured from baseline up to 24 months |
| Stage 2: To assess whether additional intraoperative imaging to standard of care improves Overall Survival (OS) | OS (time from randomisation to death or trial closure) | 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) | PFS (time from randomisation to radiological tumour progression on imaging, as agreed in local MDT This involves using the post-operative MRI scan as a reference point and making comparisons will the ensuing MRI reports that are recieved 3 months post-surgery and 3 monthly thereafter until 24 months post-surgery. | 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 | Extent of resection as percent of pre-operative tumour volume on postoperative contrast enhanced MRI | Measured 1 week post-surgery |
| Stage 2: To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) changes the incidence of surgical complications | Number and type of surgical complications | Measured from surgery up to 24 months |
| Stage 2: To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) changes the number of patients eligible for adjuvant treatment following surgery | Number of patients eligible for adjuvant treatment | Measured 3 months post surgery |
| Stage 2: To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) changes functional outcome postoperatively | Measured by any change in the functional performance assessment which consistes of a combination of:
Assessments are made at baseline, at hospital discharge, 6 weeks post-op, 3 months post-op, then 3 monthly thereafter until 24 months. | Measured from baseline up to 24 months |
| Stage 2: Assess the correlation of proxy to participant classification assessment of quality of life | Assessed using comparisons between the patient and proxy responses to the Quality of Life questionnaires administered. Specifically comparisons between the answers to questions 29 and 30 of the QLQ-C30. | Measured from baseline up to 24 months. Proxy will not complete questionnaires when participant stops completing them. |
| 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. | To assess the sensitivity and specificity of iUS* to identify the tumour boundary when compared with 5-ALA, navigated biopsies will be taken from tumour boundary tissue planned for resection. Intra operative iUS* images and post-operative MRI scans and Intraoperative biopsy samples | 6 weeks post-surgery |
| Royal Sussex County Hospital | Not yet recruiting | Brighton | BN2 5BE | United Kingdom |
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| Southmead Hospital, North Bristol NHST | Recruiting | Bristol | BS10 5NB | United Kingdom |
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| Addenbrookes Hospital, Cambridge University NHSFT | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
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| University Hospital of Wales, Cardiff & Vale University Health Board | Recruiting | Cardiff | CF14 4XW | United Kingdom |
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| University Hospital, Coventry | Not yet recruiting | Coventry | CV2 2DX | United Kingdom |
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| Ninewells Hospital, NHS Tayside | Recruiting | Dundee | DD2 1SG | United Kingdom |
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| The Royal Infirmary of Edinburgh, NHS Lothian | Recruiting | Edinburgh | EH16 | United Kingdom |
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| Hull Royal Infirmary | Recruiting | Hull | HU3 2JZ | United Kingdom |
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| Leeds General Infirmary | Recruiting | Leeds | LS1 3EX | United Kingdom |
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| The Walton Centre | Recruiting | Liverpool | L9 7LJ | United Kingdom |
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| Royal London Hospital, Barts Health NHS Trust | Recruiting | London | E1 1BB | United Kingdom |
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| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
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| Charing Cross Hospital/St Mary's, Imperial College Healthcare NHS Trust | Recruiting | London | W6 8RF | United Kingdom |
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| James Cook University Hospital, South Tees Hospitals NHSFT | Recruiting | Middlesbrough | TS4 3BW | United Kingdom |
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| Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT | Not yet recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
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| Queen's Medical Centre, Nottingham University Hospitals NHST | Recruiting | Nottingham | NG7 2UH | United Kingdom |
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| The John Radcliffe Hospital, Oxford University Hospitals NHSFT | Recruiting | Oxford | OX3 9DU | United Kingdom |
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| Derriford Hospital, University Hospitals Plymouth NHS Trust | Recruiting | Plymouth | PL6 8DH | United Kingdom |
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| Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT | Not yet recruiting | Preston | PR2 9HT | United Kingdom |
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| Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHST | Not yet recruiting | Romford | RM7 0AG | United Kingdom |
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| Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust | Not yet recruiting | Sheffield | S10 2JF | United Kingdom |
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| Southampton General Hospital, University Hospital Southampton NHSFT | Recruiting | Southampton | United Kingdom |
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| Royal Stoke University Hospital, University Hospitals of North Midlands NHST | Recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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