Brain NeoplasmsNCT02884947
Improving Surgical Outcomes in Patients With Low Grade Gliomas Using Advanced Pre- and Intra-operative MRI
An observational study of Brain Neoplasms, run by University College, London at 1 site in United Kingdom.
Trial summary
This aim of this study is to improve the outcomes for patient with gliomas undergoing neurosurgery by maximising the extent of resection whilst minimising neurological morbidity. This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages of the patients' clinical management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Dec 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intrinsic brain tumours which require surgical resection
Who may be able to join
- Intrinsic brain tumour requiring resection
- Aged 18 years or over
Who cannot join
- Inability to give consent
- Contraindication to MRI
- No English language comprehension
Trial locations and contacts
1 site in 1 country.
About this study
This aim of this study is to improve the outcomes for patient with gliomas undergoing neurosurgery by maximising the extent of resection whilst minimising neurological morbidity. This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages of the patients' clinical management.
Read the detailed description
Low grade gliomas are often located near to and infiltrate into important parts of brain which are involved with language and motor function. During surgery to remove these tumours, there is a fine balance between trying to remove as much of the tumour as possible and limiting any damage to these functionally important parts of the brain which, particularly in a young patient, may result in impairment for the rest of their life.
Functional MRI (fMRI) can be used to identify these functionally important cortical areas and diffusion tensor imaging (DTI) can be used to identify the important subcortical and deep white matter tracts connecting these regions. The use of these advanced imaging techniques performed pre-operatively to plan surgery is now commonplace however their role in guiding the actual operation itself is limited because of the occurrence of 'brain shift', this being deformation in the contour of the brain parenchyma which occurs as the tumour is resected. This can result in inaccuracies if the pre-operative advanced MRI data is being used in the neuronavigational system to guide surgery.
The main aim of this study is to determine the optimal method of providing updated, spatially accurate data on the location of these functionally important areas of the brain to the neurosurgeon intra-operatively. In this study, two different techniques will be compared. The first is the acquisition of real-time fMRI and DTI acquired intra-operatively during tumour resection. The second is to use intra-operatively acquired structural and diffusion sequences to perform non-rigid co-registration of fMRI and DTI data which has been acquired before surgery. The feasibility and then the accuracy of these two techniques will be evaluated.
The second aim of this study is to better understand the effect that the tumour and surgery have on language function as this will have important implications on the planning of the surgical approach, the counselling of patients of the possible risks of surgery and in helping to decide long term treatments. This will be achieved by performing advanced MRI scans, in particular an extensive language fMRI paradigm pre-operatively and post-operatively in patients with gliomas undergoing surgery. This will be combined with clinical testing of language function. Greater understanding of the neural plasticity in this functionally important system could allow for a greater, maximal resection.
- Conditions
- Brain Neoplasms
- Keywords
- Brain Neoplasms, Magnetic Resonance Imaging, Neurosurgery
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically applicable intra-operatively acquired fMRI data.
The intra-operatively acquired fMRI data will be assessed by a neuroradiologist, experienced in the interpretation of fMRI data for application to neurosurgical planning. The data will be evaluated using a 3 point scoring system.
Measured: 6 months following completion of data collection for 31 participants.
Number of participants with spatially accurate co-registered pre-operative DTI data.
The pre-operatively acquired DTI data, which has been co-registered using a non-rigid algorithm to intra-operatively acquired structural data, will be assessed for accuracy by comparison with intra-operatively acquired DTI using the Dice similarity coefficient (DSC).
Measured: 12 months following completion of data collection for 31 participants.
Change in language fMRI data for participants
The language fMRI data for participants will be compared with language fMRI data from a
control group to assess for both group and individual differences. This will be performed using multivariate regression in the analysis program: Statistical Parametric Mapping.
Measured: 12 months following completion of data collection collection for 31 participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Tarek Yousry, Dr. med. Habil, FRCR, Principal investigator, Neuroradiological Academic Unit, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884947
- Sponsor's protocol ID
- 12/0336
- Other IDs
- 12/LO/1977
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Outcomes in Patients With Low Grade Gliomas Using Advanced Pre- and Intra-operative MRI
- ClinicalTrials.gov ID
- NCT02884947
- Acronym / sponsor ID
- 12/0336
- Conditions
- Brain Neoplasms
- Keywords
- Brain Neoplasms, Magnetic Resonance Imaging, Neurosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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.
This aim of this study is to improve the outcomes for patient with gliomas undergoing neurosurgery by maximising the extent of resection whilst minimising neurological morbidity. This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages of the patients' clinical management.
Detailed description
Low grade gliomas are often located near to and infiltrate into important parts of brain which are involved with language and motor function. During surgery to remove these tumours, there is a fine balance between trying to remove as much of the tumour as possible and limiting any damage to these functionally important parts of the brain which, particularly in a young patient, may result in impairment for the rest of their life.
Functional MRI (fMRI) can be used to identify these functionally important cortical areas and diffusion tensor imaging (DTI) can be used to identify the important subcortical and deep white matter tracts connecting these regions. The use of these advanced imaging techniques performed pre-operatively to plan surgery is now commonplace however their role in guiding the actual operation itself is limited because of the occurrence of 'brain shift', this being deformation in the contour of the brain parenchyma which occurs as the tumour is resected. This can result in inaccuracies if the pre-operative advanced MRI data is being used in the neuronavigational system to guide surgery.
The main aim of this study is to determine the optimal method of providing updated, spatially accurate data on the location of these functionally important areas of the brain to the neurosurgeon intra-operatively. In this study, two different techniques will be compared. The first is the acquisition of real-time fMRI and DTI acquired intra-operatively during tumour resection. The second is to use intra-operatively acquired structural and diffusion sequences to perform non-rigid co-registration of fMRI and DTI data which has been acquired before surgery. The feasibility and then the accuracy of these two techniques will be evaluated.
The second aim of this study is to better understand the effect that the tumour and surgery have on language function as this will have important implications on the planning of the surgical approach, the counselling of patients of the possible risks of surgery and in helping to decide long term treatments. This will be achieved by performing advanced MRI scans, in particular an extensive language fMRI paradigm pre-operatively and post-operatively in patients with gliomas undergoing surgery. This will be combined with clinical testing of language function. Greater understanding of the neural plasticity in this functionally important system could allow for a greater, maximal resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intrinsic brain tumours which require surgical resection
Key inclusion criteria (2 listed)
- Intrinsic brain tumour requiring resection
- Aged 18 years or over
Key exclusion criteria (3 listed)
- Inability to give consent
- Contraindication to MRI
- No English language comprehension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with clinically applicable intra-operatively acquired fMRI data.
Time frame: 6 months following completion of data collection for 31 participants.
The intra-operatively acquired fMRI data will be assessed by a neuroradiologist, experienced in the interpretation of fMRI data for application to neurosurgical planning. The data will be evaluated using a 3 point scoring system.
Number of participants with spatially accurate co-registered pre-operative DTI data.
Time frame: 12 months following completion of data collection for 31 participants.
The pre-operatively acquired DTI data, which has been co-registered using a non-rigid algorithm to intra-operatively acquired structural data, will be assessed for accuracy by comparison with intra-operatively acquired DTI using the Dice similarity coefficient (DSC).
Change in language fMRI data for participants
Time frame: 12 months following completion of data collection collection for 31 participants.
The language fMRI data for participants will be compared with language fMRI data from a control group to assess for both group and individual differences. This will be performed using multivariate regression in the analysis program: Statistical Parametric Mapping.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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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.
Prof Tarek Yousry, Dr. med. Habil, FRCR principal investigator
Neuroradiological Academic Unit, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasms, run by University College, London at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically applicable intra-operatively acquired fMRI data. (time frame: 6 months following completion of data collection for 31 participants.). The study lists 3 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 9 Apr 2018.