Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis (MS)
• Interventions: Procedure: SC MRI; Other: patient questionnaire

• Registration Number: NCT04819737
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Study Start: 2022-07-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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):

  1. Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)
  2. Pacemaker
  3. Claustrophobia
  4. Pregnancy, lactation
  5. Known hypersensitivity to gadolinium-based contrast media

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord MRI	SC MRI	-
Spinal Cord MRI	patient questionnaire	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel, Department of Neurology; 🇨🇭 Basel, Switzerland