Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Study Overview
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Brief Summary
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This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Detailed Description
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An averaged magnetization inversion recovery acquisitions (AMIRA) sequence was proposed for SC MRI. This MR-sequence delivers excellent contrast between the SC gray and white matter as well as between the SC and cerebrospinal fluid (CSF) in clinically feasible-acquisition times. Moreover, the high quality and in-plane resolution of AMIRA images allows for segmentation of the SC gray and white matter with high accuracy and reproducibility. This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Official Title
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Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences: A Pilot Study

Conditions
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Multiple Sclerosis (MS)

Intervention / Treatment
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* Procedure: SC MRI
* Other: patient questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of multiple sclerosis according to established international criteria Steroid free period: > 4 weeks Participation in the Swiss MS Cohort (SMSC) study Exclusion Criteria: . History of severe (other) neurological, internal or psychiatric disease with SC affection MRI-related exclusion criteria (questionnaire): Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC) Pacemaker Claustrophobia Pregnancy, lactation Known hypersensitivity to gadolinium-based contrast media

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All participants (embedded within the currently ongoing Swiss MS Cohort (SMSC) study) will undergo a single visit including a clinical interview, neurological examination and MRI.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord MRI<br> | Procedure: SC MRI<br>* SC MRI (Averaged Magnetization Inversion Recovery Acquisitions (AMIRA), standard conventional SC MRI sequences, additional sequences for spinal cord MRI (sagittal-2D or 3D short tau inversion recovery, sagittal-2D or 3D phase-sensitive inversion recovery, 3D magnetization prepared 2 rapid acquisition gradient echoes (MPRAGE)). To evaluate the presences of ongoing inflammation (acute or chronic) in the SC of patients, 3D MPRAGE and 3D fluid-attenuated inversion recovery images after intravenous gadolinium (Gd) contrast administration (0.1 mmol per kg body weight) will be acquired.<br>Other: patient questionnaire<br>* 12-item multiple sclerosis walking scale (MSWS-12) questionnaire: self-report measure of the impact of MS on the individual's walking ability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SC lesions | Number of SC lesions using AMIRA compared to gold-standard conventional SC MRI sequences | one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time) | 
| Inter-observer agreement on SC lesion count | Inter-observer agreement with regard to lesion detection using AMIRA compared to gold-standard conventional SC MRI sequences. | one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time) | 
| Presence of ongoing inflammation (acute or chronic) in the SC | Presence of ongoing inflammation (acute or chronic) in the SC 3D MPRAGE and 3D fluid-attenuated inversion recovery images after intravenous gadolinium (Gd) contrast administration (0.1 mmol per kg body weight) | one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord (SC) pathology, demyelinating lesions, Spinal cord MRI, Averaged magnetization inversion recovery acquisitions (AMIRA) sequence, Swiss MS Cohort (SMSC)