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Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

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ClinicalTrials.gov Identifier: NCT04819737
Recruitment Status : Not yet recruiting
First Posted : March 29, 2021
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Freie Akademische Gesellschaft Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences: A Pilot Study
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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):

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819737


Contacts
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Contact: Katrin Parmar, PD Dr. med. +41 61 83 65 214 katrin.parmar@unibas.ch
Contact: Charidimos Tsagkas, Dr. med. charidimos.tsagkas@usb.ch

Locations
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Switzerland
University Hospital Basel, Department of Neurology
Basel, Switzerland, 4031
Contact: Katrin Parmar, PD Dr. med.       katrin.parmar@unibas.ch   
Principal Investigator: Katrin Parmar, PD Dr. med.         
Sub-Investigator: Charidimos Tsagkas, Dr. med.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Freie Akademische Gesellschaft Basel
Investigators
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Principal Investigator: Katrin Parmar, PD Dr. med. University Hospital Basel, Department of Neurology
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04819737    
Other Study ID Numbers: 2021-00269; ko21Parmar
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
spinal cord (SC) pathology
demyelinating lesions
Spinal cord MRI
Averaged magnetization inversion recovery acquisitions (AMIRA) sequence
Swiss MS Cohort (SMSC)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases