Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Multiple Sclerosis (MS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819737
• Other study ID #: 2021-00269; ko21Parmar
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Katrin Parmar, PD Dr. med.
• Phone: +41 61 83 65 214
• Email: katrin.parmar[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Neurology	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Freie Akademische Gesellschaft Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of SC lesions	Number of SC lesions using AMIRA compared to gold-standard conventional SC MRI sequences	one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Primary	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.	one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Primary	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)	one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)