Single Test to ARrive at MS Diagnosis. Using a Single MRI Brain Scan to Help Diagnose Multiple Sclerosis

NCT02485223 | Unknown

• 2 other identifiers: 15022 [Sponsor reference]15/NW/0286
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; Diagnostic test; Central veins; MRI

Outcome Measures

Primary Outcomes (1)

• Difference in the proportion of central veins:lesions in patients with MS and non-MS.

  To detect this difference with an alpha of 0.05 and power of 0.8, (based on previous data that shows a mean proportion of approx. 60% in MS patients and 6% in ischaemic patients) we will need 12 patients with MS and 12 with non-MS at 1 year of follow up. However given the fact that approx. 40% of patients will have a diagnosis of MS at 1 year, we will need to scan 60 patients in total.

  After 1 year of follow up with a confirmed diagnosis.

Secondary Outcomes (7)

• Sensitivity of using a proportion of central veins:lesions in diagnosing MS.

  After 1 year of follow up with a confirmed diagnosis

• Specificity of using a proportion of central veins:lesions in diagnosing MS.

  After 1 year of follow up with a confirmed diagnosis

• Positive predictive value of the central vein:lesion MRI test.

  After 1 year of follow up with a confirmed diagnosis

• Negative predictive value of the central vein:lesion MRI test.

  After 1 year of follow up with a confirmed diagnosis

• Optimal proportion of central veins:lesions to make a diagnosis of MS.

  After 1 year of follow up with a confirmed diagnosis.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will recruit patients who attend the general neurology and MS clinics at Nottingham University Hospitals (NUH) NHS Trust, UK. The researchers anticipate that the study population will comprise of two groups: the common presentation of young individuals following the first neurological symptoms suggestive of MS, however the neuroradiologist's report of the MRI will not be in agreement with the neurological impression; and a group of patients who present with atypical symptoms for MS but the MRI scan is reported as suggestive of MS.

You may qualify if:

• Able to tolerate an MRI brain scan
• No contraindications to MRI
• Radiological suspicion of MS, but clinically atypical or Clinical suspicion of MS, but radiologically atypical
• Radiological or clinical suspicion of any of the following with a routine MRI brain scan showing white matter lesions; Autoimmune/Inflammatory; Antiphospholipid syndrome, Neurosarcoidosis, Neuro-Behcet's disease, Neuromyelitis Optica, Systemic lupus erythematosus, Primary CNS vasculitis, Secondary CNS vasculitis, Sjogren's syndrome, Susac syndrome. Ischaemic; Hypertensive ischaemic disease (small vessel disease), embolic disease. Infective ; Lyme disease, Cytomegalovirus CNS infection, Toxocariasis, Neurocysticercosis, Whipple's disease, Progressive Multifocal Leukoencephalopathy, Herpes virus (HHV) infection e.g VZV, HIV, Toxoplasmosis, Tuberculosis, Neurosyphilis. Neoplastic; Lymphoma, Glioma, Primary CNS Lymphoma, Cerebral metastases. Other; CADASIL, Histiocytosis, Migraine, Mitochondrial disease, Leukodystrophy.

You may not qualify if:

• Unable to tolerate a further MRI scan
• Unsafe to perform an MRI scan
• Pregnancy
• Participants with normal routine clinical scans
• Unable to give written informed consent

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (4)

• Tallantyre EC, Brookes MJ, Dixon JE, Morgan PS, Evangelou N, Morris PG. Demonstrating the perivascular distribution of MS lesions in vivo with 7-Tesla MRI. Neurology. 2008 May 27;70(22):2076-8. doi: 10.1212/01.wnl.0000313377.49555.2e. No abstract available.

  PMID: 18505982 BACKGROUND

• Tallantyre EC, Dixon JE, Donaldson I, Owens T, Morgan PS, Morris PG, Evangelou N. Ultra-high-field imaging distinguishes MS lesions from asymptomatic white matter lesions. Neurology. 2011 Feb 8;76(6):534-9. doi: 10.1212/WNL.0b013e31820b7630.

  PMID: 21300968 BACKGROUND

• Mistry N, Dixon J, Tallantyre E, Tench C, Abdel-Fahim R, Jaspan T, Morgan PS, Morris P, Evangelou N. Central veins in brain lesions visualized with high-field magnetic resonance imaging: a pathologically specific diagnostic biomarker for inflammatory demyelination in the brain. JAMA Neurol. 2013 May;70(5):623-8. doi: 10.1001/jamaneurol.2013.1405.

  PMID: 23529352 BACKGROUND

• Sati P, George IC, Shea CD, Gaitan MI, Reich DS. FLAIR*: a combined MR contrast technique for visualizing white matter lesions and parenchymal veins. Radiology. 2012 Dec;265(3):926-32. doi: 10.1148/radiol.12120208. Epub 2012 Oct 16.

  PMID: 23074257 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr Nikos Evangelou, MD

  Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: June 30, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

GB (1)