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DECISIve - DiagnosE Using the Central veIn SIgn v1.0 (DECISiVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05533905
Recruitment Status : Active, not recruiting
First Posted : September 9, 2022
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Brief Summary:
DECISIve - DiagnosE using the Central veIn SIgn. A prospective diagnostic superiority study comparing T2* MRI and lumbar puncture in patients presenting with possible Multiple Sclerosis

Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: Lumbar puncture Diagnostic Test: MRI

Detailed Description:

There is currently no agreement on the best way to diagnose Multiple Sclerosis (MS). Frequently, people suspected of having MS have a standard MRI scan and undergo a 'lumbar puncture' (a thin needle is inserted between the bones in the lower spine). Patients often report they find it painful and it can cause unintended complications requiring hospitalisations or time off work to recover.

Although the fluid taken during a lumbar puncture can show evidence of disease, this is not always the case. We do not find abnormalities in everyone who has MS but some people with conditions that can mimic MS, but need very different treatment, have similar lumbar puncture abnormalities. Both of these problems can lead to misdiagnosis.

A new MRI scan allows us to see small veins that run through damaged areas of the brain in people with MS. It has been shown that this is a specific finding to MS, seldom seen in other conditions. It is not painful and carries few or no risks.

This research aims to change the way people are diagnosed with MS and reduce the number of lumbar punctures used. Our team will recruit a large number of people from different hospitals whose doctors suspect they may have MS. We will invite them to have the new eight-minute MRI scan. After 18 months, we will find out what diagnosis is eventually reached and compare this to the finding of the new scan. We will compare the accuracy, speed, costs and acceptability of the different tests needed to make a diagnosis of MS and establish if most lumbar punctures can be replaced by a slightly longer MRI scan. This research could provide the NHS with a scientific approach to diagnose MS which is safer, more cost effective and importantly, more acceptable to patients.

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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DECISIve - DiagnosE Using the Central veIn SIgn. A Prospective Diagnostic Superiority Study Comparing T2*MRI and Lumbar Puncture in Patients Presenting With Possible Multiple Sclerosis.
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : November 6, 2023
Estimated Study Completion Date : November 6, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Lumbar puncture
    A thin needle is inserted between the bones in the spine.
  • Diagnostic Test: MRI
    A scan of the head.


Primary Outcome Measures :
  1. Is T2* MRI scan more sensitive than lumbar puncture with oligoclonal band testing for diagnosing MS at the time of first clinical presentation? [ Time Frame: 18 months ]
    Comparison of MRI and lumbar puncture in diagnosing MS.


Secondary Outcome Measures :
  1. Is there a significant difference between the specificity of each diagnostic test in this cohort? [ Time Frame: 18 months ]
    Is there a difference in the quality of the diagnostic tests.

  2. Is there a significant difference between the sensitivity and specificity of the 'rule of six' proposed in Mistry et al. 2016 and lumbar puncture with oligoclonal bands? [ Time Frame: 18 months ]
    Comparison with past research



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 115 participants will be recruited over 30 months across the four participating sites.
Criteria

Inclusion Criteria:

  • Presentation with a typical clinically isolated syndrome (Thompson et al. 2017) for diagnostic evaluation of MS.

Exclusion Criteria:

  1. Fulfils the diagnosis of MS, as defined by the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2017).
  2. Unwilling or unable to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.
  3. Unable to provide informed consent.
  4. Contraindication or inability to undergo MRI due to metal or metal implants, pregnancy, claustrophobia, pain, spasticity, or excessive movement related to tremor.
  5. Acute COVID-19 infection at time of face-to-face interactions during study (unless investigations can be delayed until considered safe by the responsible clinician and PI) either diagnosed clinically or by acute infection testing
  6. Participant required to self-isolate at time of face-to-face interactions during study (unless investigations can be delayed until considered safe by the responsible clinician and PI) due to COVID-19 exposure, shielding due to medical advice, public health advice or governmental advice/laws.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05533905


Locations
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United Kingdom
NUH NHS Trust
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
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Principal Investigator: Nikos Evangelou NUH NHS Trust
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT05533905    
Other Study ID Numbers: 19NS022
First Posted: September 9, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases