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Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Primary Purpose

Multiple Sclerosis (MS)

Status

Not yet recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

SC MRI

patient questionnaire

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis (MS) focused on measuring spinal cord (SC) pathology, demyelinating lesions, Spinal cord MRI, Averaged magnetization inversion recovery acquisitions (AMIRA) sequence, Swiss MS Cohort (SMSC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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):
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

Sites / Locations

University Hospital Basel, Department of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord MRI

Arm Description

Outcomes

Primary Outcome Measures

Number of SC lesions

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

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.

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04819737

First Posted

March 24, 2021

Last Updated

May 17, 2022

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Freie Akademische Gesellschaft Basel

1. Study Identification

Unique Protocol Identification Number

NCT04819737

Brief Title

Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2022 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Freie Akademische Gesellschaft Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis (MS)

Keywords

spinal cord (SC) pathology, demyelinating lesions, Spinal cord MRI, Averaged magnetization inversion recovery acquisitions (AMIRA) sequence, Swiss MS Cohort (SMSC)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spinal Cord MRI

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

SC MRI

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

patient questionnaire

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of SC lesions

Description

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)

Title

Inter-observer agreement on SC lesion count

Description

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)

Title

Presence of ongoing inflammation (acute or chronic) in the SC

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katrin Parmar, PD Dr. med.

Phone

+41 61 83 65 214

katrin.parmar@unibas.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Charidimos Tsagkas, Dr. med.

charidimos.tsagkas@usb.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katrin Parmar, PD Dr. med.

Organizational Affiliation

University Hospital Basel, Department of Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Basel, Department of Neurology

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katrin Parmar, PD Dr. med.

katrin.parmar@unibas.ch

First Name & Middle Initial & Last Name & Degree

Katrin Parmar, PD Dr. med.

First Name & Middle Initial & Last Name & Degree

Charidimos Tsagkas, Dr. med.

12. IPD Sharing Statement

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Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

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