Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04819737

Collaborator

Freie Akademische Gesellschaft Basel (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis (MS)	Procedure: SC MRI Other: patient questionnaire	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinal Cord MRI	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 gadolinium (Gd) contrast administration (0.1 mmol per kg body weight) will be acquired. 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

Arm

Intervention/Treatment

Experimental: Spinal Cord MRI

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 gadolinium (Gd) contrast administration (0.1 mmol per kg body weight) will be acquired.

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

Outcome Measures

Primary Outcome Measures

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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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