Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04819737
Recruitment Status : Not yet recruiting
First Posted : March 29, 2021
Last Update Posted : November 2, 2021
Sponsor:
Collaborator:
Freie Akademische Gesellschaft Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : March 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Katrin Parmar, PD Dr. med. University Hospital Basel, Department of Neurology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: November 2, 2021
Last Verified: November 2021

Layout table for additional information
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:
Layout table for MeSH terms
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