Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02485223
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2015-04-23
Brief Title:
Single Test to ARrive at MS Diagnosis Using a Single MRI Brain Scan to Help Diagnose Multiple Sclerosis
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Single Test to ARrive at MS Diagnosis A Prospective Longitudinal Investigator Blinded Pilot Study Assessing the Accuracy of a Single 3 Tesla MRI Scan in Predicting Multiple Sclerosis in Cases of Diagnostic Uncertainty
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-MS
Brief Summary:
This is a pilot study a small scale study testing procedures so that the investigators can apply this to a larger scale study This study will test the accuracy of a new brain scan Magnetic Resonance Imaging technique in predicting the diagnosis of multiple sclerosis MS in patients where there is uncertainty about the diagnosis For patients where there is a suspicion but not definite diagnosis of MS an additional MRI brain scan will be offered There will be no other research tests and the patient is followed up to see what the eventual diagnosis is The investigators will then review the original brain scan to see if this predicted the diagnosis of MS or not
Detailed Description:
There is no single simple test to differentiate MS from conditions that mimic it Apart from the patients symptoms doctors use Magnetic Resonance Imaging MRI of the brain to see if there are abnormalities which are consistent with MS In patients without typical symptoms or a typical MRI appearance a firm diagnosis cannot be made as other neurological illnesses can mimic symptoms of MS and the MRI scans can look very similar Further tests are often required such as lumbar punctures resulting in delays discomfort for the patient and additional healthcare costs With time the diagnosis can become clearer as patients may develop other symptoms of MS but this may take months or years
The most common errors are from misinterpretation of the brain abnormalities or lesions seen on the MRI scan Subsequently if a patient is misdiagnosed with MS they may receive treatment they do not need Furthermore a delay in a firm diagnosis delays treatment for another condition With the rapid increase of new medications in the last few years accurate and rapid diagnosis is paramount
Pathologically when looking at lesions using a microscope MS lesions usually have a vein running through the centre whereas in lesions arising from other conditions the investigators hypothesize that no central vein is seen The investigators can therefore distinguish between patients with MS and patients without it
The researchers therefore want to test the value of a clinical 3-Tesla MRI brain scan in accurately distinguishing between MS and other conditions with MRI sequences that have been refined over the last few years
Patients will only have one research MRI brain scan and then be followed up by their neurologist who will confirm the final diagnosis The investigators shall then look back at the original scans to see if those with MS had veins within their lesions and if those without MS had lesions without veins
The most common errors are from misinterpretation of the brain abnormalities or lesions seen on the MRI scan Subsequently if a patient is misdiagnosed with MS they may receive treatment they do not need Furthermore a delay in a firm diagnosis delays treatment for another condition With the rapid increase of new medications in the last few years accurate and rapid diagnosis is paramount
Pathologically when looking at lesions using a microscope MS lesions usually have a vein running through the centre whereas in lesions arising from other conditions the investigators hypothesize that no central vein is seen The investigators can therefore distinguish between patients with MS and patients without it
The researchers therefore want to test the value of a clinical 3-Tesla MRI brain scan in accurately distinguishing between MS and other conditions with MRI sequences that have been refined over the last few years
Patients will only have one research MRI brain scan and then be followed up by their neurologist who will confirm the final diagnosis The investigators shall then look back at the original scans to see if those with MS had veins within their lesions and if those without MS had lesions without veins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15NW0286 | OTHER | NRES Committee North West - Greater Manchester East | None |