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Recruiting NCT04819737

Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

No phase Interventional Multiple Sclerosis (MS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SC MRI, patient questionnaire.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Procedure SC MRI
    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 g
  • Other patient questionnaire
    12-item multiple sclerosis walking scale (MSWS-12) questionnaire: self-report measure of the impact of MS on the individual's walking ability

Primary outcome measures

  • Number of SC lesions [Time frame: 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 [Time frame: 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 [Time frame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 1 center
  • University Hospital Basel, Department of Neurology — Basel

Identifiers

NCT: NCT04819737 · 2021-00269; ko21Parmar

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗