Multiple SclerosisNCT01805986
Investigation of GM Pathology Using Ultra High Field (7T) MRI Scanner
An observational study of Multiple Sclerosis, run by University of Nottingham.
Trial summary
Magnetization transfer imaging is a magnetic resonance technique that has been used over the last few years, and known for its ability to detect abnormalities that can be difficult to detect by conventional MRI techniques. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Feb 2015
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients studied will be those with known MS. For purposes of comparison as described previously, we will also seek to include healthy volunteers.
Who may be able to join
- Patients with MS or other neurological disease which already had at least 1 MRI scan.
- Healthy volunteers which had no indication of neurological disease in the past.
- Do not have significant cognitive impairment and are able to give consent.
- Will not have any contraindication for MR imaging
- Are able to lie flat for up to 60 mins.
- Age 25 and over.
Who cannot join
- Pregnancy
- Have any implants in the body.
- Have aneurysm clips.
- Have pacemaker or artificial heart valve.
- Have foreign bodies in their body (e.g. shrapnel).
About this study
Official title: Investigation of Grey Matter Pathology Using Ultra High Field (7T) MRI Scanner
Magnetization transfer imaging is a magnetic resonance technique that has been used over the last few years, and known for its ability to detect abnormalities that can be difficult to detect by conventional MRI techniques.
The investigators would like to test if using an 7 Tesla MRI research scanner can help us diagnose Multiple Sclerosis more efficiently compared to the current clinical practice, i.e. if Multiple Sclerosis lesions in Gray Matter can be more readily identified and associated with disease stage on Magnetic Transfer MRI images as opposed to conventional procedures. Image analysis will allow the investigators to perform lesion segmentation and sequence comparison between different MRI techniques. The investigators will apply computation techniques to measure the local cortical thickness. Repeated scans at 6 monthly intervals over two years will give an insight into the changes in cortical thickness over time. Based on obtained data the investigators will look for the relationship between lesion loads in White Matter and Gray Matter, cortical thickness and disease stage.
Read the detailed description
Purpose for this study:
This research group has previously investigated the usefulness of a powerful new MRI scanner and have found that the 7 Tesla MRI is able to provide detailed structural images of the cortex of the brain which can uncover pathology such as cortical demyelinating lesions in MS patients. Multiple sclerosis (MS) affects the grey matter as well as the white matter of the brain and spinal cord. However as white matter lesions are more easily visible both pathologically and on MRI, therefore most MS research has focused on white matter demyelination. The investigators would like to assess whether MS lesions in Gray Matter as well as White Matter can be more readily identified on Magnetic Transfer Ratio (MTR) images as opposed to standard protocols such as DIR, T2* and T1-weighted MPRAGE by comparing the results of the manual detection.
The investigators will correlate lesion loads against cortical thickness and both lesion loads and cortical thickness against disease state both globally and on a regional basis. The investigators will then compare averaged, normalized profiles from different cortical ribbon regions between patients and controls to determine whether a particular layer of the cortical strip is more affected. The investigators will also correlate Gray Matter changes with distant and neighboring White Matter lesions. In addition, the investigators will also build an average lesion map across all subjects, which can be compared against the results published in literature. The investigators will use the manual lesion maps to characterize the regions of the cortex that deviate from normally appearing Gray Matter.
How this project will be carried out:
The investigators will study patients with MS and other neurological disease, and patients who are followed already at the neurology. All patients would have had already a brain scan.
For comparison purposes the investigators will study healthy volunteers, in order to demonstrate that any new findings demonstrable with the 7T MRI scan are indeed related to pathology.
Ethical issues:
Occasionally the investigators discover incidental abnormalities on brain scans of those who participate in the study. In such circumstances the investigators will adhere to University of Nottingham Incidental Findings Procedure. In the Participant Information Sheet the investigators will explain that if the investigators notice any abnormality on MR scans (for healthy volunteer) or abnormality on MR scan not expected to be seen under patient's neurological diagnosis (for patients) the investigators will refer them to their GP. The investigators will send a letter to patient's GP informing that the investigators have detected a possible abnormality on the scan. The investigators will show the scans to a radiologist based in Academic Radiology at the QMC, who will contact participant's GP if further action is required.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, other neurological conditions
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Gray Matter lesions detected using different sequences.
Measured: 2 years
Secondary outcomes (4)
Comparison of MRI sequencies
To determine whether Magnetisation Transfer Ratio (MTR) maps are more sensitive for detection of cortical lesions than Double Inversion Recovery (DIR), T2* and phase maps, or Magnetisation Prepared Rapid Acquisition Gradient Echo (MPRAGE) and to better characterise cortical lesions using a combination of sequences.
Measured: 2 years
To determine the relationship between cortical thickness as measured on T1 weighted images and GM and WM lesion load.
Measured: 2 years
Regional variation in the brain
To determine the origins of regional changes previously detected via voxel based analysis and histogram analysis, using a multiscale approach, working down from identifying regional variations across the cortex, to identifying whether regional changes are associated with changes in so called Normal Appearing White Matter (NAGM), or whether they are associated with diffuse or focal GM lesions.
Measured: 2 years
To detect cortical variations in MT inside and outside GM lesions, in a longitudinal pilot study, reflecting possible cortical remyelination.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikos Evangelou, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805986
- Sponsor's protocol ID
- 12115
- Other IDs
- 13920, 12/EM/0452, 917
- Status last verified
- May 2013
- First submitted
- 5 Mar 2013
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Grey Matter Pathology Using Ultra High Field (7T) MRI Scanner
- ClinicalTrials.gov ID
- NCT01805986
- Acronym / sponsor ID
- 12115
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, other neurological conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 6 Mar 2013 (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.
Magnetization transfer imaging is a magnetic resonance technique that has been used over the last few years, and known for its ability to detect abnormalities that can be difficult to detect by conventional MRI techniques.
The investigators would like to test if using an 7 Tesla MRI research scanner can help us diagnose Multiple Sclerosis more efficiently compared to the current clinical practice, i.e. if Multiple Sclerosis lesions in Gray Matter can be more readily identified and associated with disease stage on Magnetic Transfer MRI images as opposed to conventional procedures. Image analysis will allow the investigators to perform lesion segmentation and sequence comparison between different MRI techniques. The investigators will apply computation techniques to measure the local cortical thickness. Repeated scans at 6 monthly intervals over two years will give an insight into the changes in cortical thickness over time. Based on obtained data the investigators will look for the relationship between lesion loads in White Matter and Gray Matter, cortical thickness and disease stage.
Detailed description
Purpose for this study:
This research group has previously investigated the usefulness of a powerful new MRI scanner and have found that the 7 Tesla MRI is able to provide detailed structural images of the cortex of the brain which can uncover pathology such as cortical demyelinating lesions in MS patients. Multiple sclerosis (MS) affects the grey matter as well as the white matter of the brain and spinal cord. However as white matter lesions are more easily visible both pathologically and on MRI, therefore most MS research has focused on white matter demyelination. The investigators would like to assess whether MS lesions in Gray Matter as well as White Matter can be more readily identified on Magnetic Transfer Ratio (MTR) images as opposed to standard protocols such as DIR, T2* and T1-weighted MPRAGE by comparing the results of the manual detection.
The investigators will correlate lesion loads against cortical thickness and both lesion loads and cortical thickness against disease state both globally and on a regional basis. The investigators will then compare averaged, normalized profiles from different cortical ribbon regions between patients and controls to determine whether a particular layer of the cortical strip is more affected. The investigators will also correlate Gray Matter changes with distant and neighboring White Matter lesions. In addition, the investigators will also build an average lesion map across all subjects, which can be compared against the results published in literature. The investigators will use the manual lesion maps to characterize the regions of the cortex that deviate from normally appearing Gray Matter.
How this project will be carried out:
The investigators will study patients with MS and other neurological disease, and patients who are followed already at the neurology. All patients would have had already a brain scan.
For comparison purposes the investigators will study healthy volunteers, in order to demonstrate that any new findings demonstrable with the 7T MRI scan are indeed related to pathology.
Ethical issues:
Occasionally the investigators discover incidental abnormalities on brain scans of those who participate in the study. In such circumstances the investigators will adhere to University of Nottingham Incidental Findings Procedure. In the Participant Information Sheet the investigators will explain that if the investigators notice any abnormality on MR scans (for healthy volunteer) or abnormality on MR scan not expected to be seen under patient's neurological diagnosis (for patients) the investigators will refer them to their GP. The investigators will send a letter to patient's GP informing that the investigators have detected a possible abnormality on the scan. The investigators will show the scans to a radiologist based in Academic Radiology at the QMC, who will contact participant's GP if further action is required.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patient | – | – |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients studied will be those with known MS. For purposes of comparison as described previously, we will also seek to include healthy volunteers.
Key inclusion criteria (6 listed)
- Patients with MS or other neurological disease which already had at least 1 MRI scan.
- Healthy volunteers which had no indication of neurological disease in the past.
- Do not have significant cognitive impairment and are able to give consent.
- Will not have any contraindication for MR imaging
Key exclusion criteria (5 listed)
- Pregnancy
- Have any implants in the body.
- Have aneurysm clips.
- Have pacemaker or artificial heart valve.
- Have foreign bodies in their body (e.g. shrapnel).
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
The number of Gray Matter lesions detected using different sequences.
Time frame: 2 years
4 secondary outcomes
Comparison of MRI sequencies
Time frame: 2 years
To determine the relationship between cortical thickness as measured on T1 weighted images and GM and WM lesion load.
Time frame: 2 years
Regional variation in the brain
Time frame: 2 years
To detect cortical variations in MT inside and outside GM lesions, in a longitudinal pilot study, reflecting possible cortical remyelination.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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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.
Nikos Evangelou, PhD principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Nottingham.
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 6 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The number of Gray Matter lesions detected using different sequences. (time frame: 2 years). 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 17 May 2013.