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Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

ConditionMultiple Sclerosis (MS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of multiple sclerosis according to established international criteria

Steroid free period: > 4 weeks

Participation in the Swiss MS Cohort (SMSC) study

Disqualifiers

. History of severe (other) neurological, internal or psychiatric disease with SC affection

Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)

Pacemaker

Claustrophobia

Trial design

Design model

Single group

Treatments tested in this trial

  • SC MRI

    Procedure/Surgery

    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.

  • patient questionnaire

    Other intervention

    12-item multiple sclerosis walking scale (MSWS-12) questionnaire: self-report measure of the impact of MS on the individual's walking ability

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Spinal Cord MRIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of SC lesions

Number of SC lesions using AMIRA compared to gold-standard conventional SC MRI sequences

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)
2

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.

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)
3

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)

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Freie Akademische Gesellschaft Basel

Collaborator

Source ClinicalTrials.gov
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