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NCT Number: NCT04819737

Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Department of Neurology

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Charidimos Tsagkas, Dr. med.

SUB_INVESTIGATOR

Katrin Parmar, PD Dr. med.

CONTACT

[email protected]

Katrin Parmar, PD Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SC MRI

Procedure

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

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

Primary outcomes

  1. 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)

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

  2. 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)

    Inter-observer agreement with regard to lesion detection using AMIRA compared to gold-standard conventional SC MRI sequences.

  3. 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)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Charidimos Tsagkas, Dr. med.

CONTACT

[email protected]

Katrin Parmar, PD Dr. med.

CONTACT

[email protected]

+41 61 83 65 214

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Freie Akademische Gesellschaft Basel

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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