Glioma Glioblastoma MultiformeFUTURE-GBNCT05399524
Functional and Ultrasound Guided Resection of Glioblastoma
A study testing Additional pre- and intra-operative imaging in people with Glioma Glioblastoma Multiforme, run by University of Oxford at 24 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma Glioblastoma Multiforme
- What is being tested?
- Additional pre- and intra-operative imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- 1 Nov 2020to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Midline/basal ganglia/cerebellum/brainstem GB
- Multifocal GB
- Recurrent GB
- Suspected secondary GB
- Contraindication to MRI
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites, 24 recruiting
- Not yet recruiting
Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT
Birmingham, B15 2TH
Colin Watts, c.watts.2@bham.ac.uk
- Not yet recruiting
Royal Sussex County Hospital
Brighton, BN2 5BE
Giles Critchley, giles.critchley@nhs.net
- Recruiting
Southmead Hospital, North Bristol NHST
Bristol, BS10 5NB
Neil Barua, neilbarua@doctors.org.uk
- Recruiting
Addenbrookes Hospital, Cambridge University NHSFT
Cambridge, CB2 0QQ
Stephen Price, sjp58@cam.ac.uk
- Recruiting
University Hospital of Wales, Cardiff & Vale University Health Board
Cardiff, CF14 4XW
George Eralil, george.eralil@wales.nhs.uk
- Not yet recruiting
University Hospital, Coventry
Coventry, CV2 2DX
Sandeep Solanki, Sandeep.Solanki@uhcw.nhs.uk
- Recruiting
Ninewells Hospital, NHS Tayside
Dundee, DD2 1SG
Anna Solth, anna.solth1@nhs.scot
- Recruiting
The Royal Infirmary of Edinburgh, NHS Lothian
Edinburgh, EH16
Paul Brennan, paul.brennan@ed.ac.uk
- Recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
Chittoor Rajaraman, chittoor.rajaraman@nhs.net
- Recruiting
Leeds General Infirmary
Leeds, LS1 3EX
Robert Corns, robertcorns@nhs.net
- Recruiting
The Walton Centre
Liverpool, L9 7LJ
Michael Jenkinson, Michael.Jenkinson@liverpool.ac.uk
- Recruiting
Royal London Hospital, Barts Health NHS Trust
London, E1 1BB
Edward McKintosh, edward.mckintosh@nhs.net
- Recruiting
King's College Hospital
London, SE5 9RS
Keyoumars Ashkan, k.ashkan@nhs.net
- Recruiting
Charing Cross Hospital/St Mary's, Imperial College Healthcare NHS Trust
London, W6 8RF
Sophie Camp, sophie.camp@nhs.net
Dipankar Nandi, dipankar.nandi@nhs.net
- Recruiting
James Cook University Hospital, South Tees Hospitals NHSFT
Middlesbrough, TS4 3BW
Anil Varma, anil.varma@nhs.net
- Not yet recruiting
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT
Newcastle upon Tyne, NE1 4LP
Damian Holliman, damian.holliman@nhs.net
- Recruiting
Queen's Medical Centre, Nottingham University Hospitals NHST
Nottingham, NG7 2UH
Stuart Smith, stuart.smith@nottingham.ac.uk
- Recruiting
The John Radcliffe Hospital, Oxford University Hospitals NHSFT
Oxford, OX3 9DU
Puneet Plaha, Puneet.plaha@ouh.nhs.uk
- Recruiting
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
James Palmer, jamespalmer1@nhs.net
- Not yet recruiting
Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT
Preston, PR2 9HT
Isaac Phang, Isaac.Phang@LTHTR.nhs.uk
- Not yet recruiting
Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHST
Romford, RM7 0AG
Nik Haliasos, n.haliasos@nhs.net
- Not yet recruiting
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Yahia Al-Tamimi, yahia.al-tamimi@nhs.net
- Recruiting
Southampton General Hospital, University Hospital Southampton NHSFT
Southampton
Paul Grundy, paul.grundy@nhs.net
- Recruiting
Royal Stoke University Hospital, University Hospitals of North Midlands NHST
Stoke-on-Trent, ST4 6QG
Erminia Albanese, Erminia.Albanese@uhnm.nhs.uk
About this study
Official title: FUTURE-GB Trial (Functional and Ultrasound-guided Resection of Glioblastoma) A 2-Stage Trial. A Learning Phase Evaluation of Participating Centres, Followed by a Randomised, Controlled Multicentre Phase III Trial.
Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours
Read the detailed 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:
- Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm)
- 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
- Glioma Glioblastoma Multiforme
- Being tested
- Standard of Care, Additional pre- and intra-operative imaging
- Keywords
- DTI, iUS
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Neuronavigation and intraoperative 5-ALA
Additional pre- and intra-operative imagingOther
Also called DTI, IUS
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)
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: 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). Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Operation length, in normal range for this surgery.
- 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.
- Extent of tumour resection (cm³ remaining) on postoperative MRI scan.
- 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: 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:
- 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.
- Progression Free Survival (PFS). This is measured by radiological tumour progression on imaging, which is taken 3-months post-op and 3-monthly thereafter.
- Overall Survival (OS) with an event defined as either deterioration, progression or death.
Measured: 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
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.
Measured: 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: 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)
Measured: 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.
Measured: 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: 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: 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: 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:
- The WHO (World Health Organisation) performance status
- A 5-minute telephone mini-MoCA (The Montreal Cognitive Assessment, Montreal Version)
- Barthel Index
- MRC (Medical Research Council) grading of power in all 4 limbs
Assessments are made at baseline, at hospital discharge, 6 weeks post-op, 3 months post-op, then 3 monthly thereafter until 24 months.
Measured: 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: Measured from baseline up to 24 months. Proxy will not complete questionnaires when participant stops completing them.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Nov 2020
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Efficacy and Mechanism Evaluation (EME) Programme
- Responsible party
- Sponsor
- Investigators
- Puneet Plaha, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399524
- Sponsor's protocol ID
- 14763
- Acronym
- FUTURE-GB
- Status last verified
- Apr 2022
- First submitted
- 24 Nov 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUTURE-GB Trial (Functional and Ultrasound-guided Resection of Glioblastoma) A 2-Stage Trial. A Learning Phase Evaluation of Participating Centres, Followed by a Randomised, Controlled Multicentre Phase III Trial.
- ClinicalTrials.gov ID
- NCT05399524
- Acronym / sponsor ID
- FUTURE-GB / 14763
- Conditions
- Glioma Glioblastoma Multiforme
- Keywords
- DTI, iUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Efficacy and Mechanism Evaluation (EME) Programme
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours
Detailed 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:
- Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Additional pre- and intra-operative imaging | Experimental | Other: Additional pre- and intra-operative imagingSurgery 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)) |
| Standard of Care | Active comparator | Other: Standard of CareThe comparator is standard care as per current NICE guidelines (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-ALA). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Midline/basal ganglia/cerebellum/brainstem GB
- Multifocal GB
- Recurrent GB
- Suspected secondary GB
- Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareNeuronavigation and intraoperative 5-ALA | Other | Standard of Care |
| Additional pre- and intra-operative imagingAlso: DTI, IUSAdditional 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) | Other | Additional pre- and intra-operative imaging |
Primary outcome
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.
Time frame: Measured 6 weeks post-surgery
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.
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)
Time frame: Measured from baseline up to 24 months
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.
9 secondary outcomes
Stage 2: To assess if additional intraoperative imaging changes DFS where deterioration relates to physical and social functioning, and motor and communication dysfunction
Time frame: Measured from baseline up to 24 months
Stage 2: To assess whether additional intraoperative imaging to standard of care changes time to deterioration
Time frame: Measured from baseline up to 24 months
Stage 2: To assess whether additional intraoperative imaging to standard of care improves Overall Survival (OS)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured from baseline up to 24 months
Stage 2: Assess the correlation of proxy to participant classification assessment of quality of life
Time frame: Measured from baseline up to 24 months. Proxy will not complete questionnaires when participant stops completing them.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puneet Plaha study director
University of Oxford
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional pre- and intra-operative imaging in people with Glioma Glioblastoma Multiforme, run by University of Oxford at 24 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Taylor (44 7917 101 649, futuregb@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Measured 6 weeks post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.