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Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis

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ClinicalTrials.gov Identifier: NCT04369898
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date April 27, 2020
First Posted Date April 30, 2020
Last Update Posted Date August 4, 2020
Actual Study Start Date June 1, 2010
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2020)
  • differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity) [ Time Frame: at Baseline ]
    differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
  • differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity) [ Time Frame: at Baseline ]
    differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
  • specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis [ Time Frame: at Baseline ]
    specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
  • sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis [ Time Frame: at Baseline ]
    sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis
Official Title A Multi-centric Study of the Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis
Brief Summary This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
Detailed Description CLs and LCLs may be detected at 3 Tesla (T) MRI by using dedicated sequences. 3D Double inversion recovery (DIR), Phase-Sensitive Inversion Recovery (PSIR), Magnetization Prepared - RApid Gradient Echo (MPRAGE) and Magnetization Prepared - 2- RApid Gradient Echo (MP2RAGE) have all shown variable sensitivity to CLs and LCLs. The central vein sign (CVS, i.e. the detection of a central vessel in a focal lesion) has been recently proposed as a biomarker for distinguishing between MS and not and not MS. Both the presence of CL and CVs brings high sensitivity and specificity in distinguishing MS from not MS patients; whether their combination achieves higher sensitivity and specificity to MS diagnosis and differential diagnosis is to date not know. This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

MRI and clinical coded data will be collected from some of the European centers that belong to the MAGNIMS consortium (Oxord University, University College London, University Hospital Vall d'Hebron (Barcelona), Verona University) as well as from Basel University hospital. MAGNIMS members and associate centers have a common data-sharing agreement (enclosed).

MAGNIMS is an independent European network of academics that share a common interest in the study of multiple sclerosis (MS) using magnetic resonance imaging (MRI). MRI data must have been collected at 3T between 1990 and 2020.

Condition Multiple Sclerosis)
Intervention
  • Other: Image analysis/ Central vein detection
    Image analysis/ Central vein detection will be performed using a fully automated approach based on an ensemble of 3D convolutional neural Networks. The method is applied to T1w, T2w and T2*w data . Results will be manually reviewed by 2 experts in CVs detection. MRI data must have been collected at 3 Tesla (3T) between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection).
  • Other: Image analysis/ Automatic cortical lesion detection
    Image analysis/ Automatic cortical lesion detection will be performed by using a convolutional neural network-based method. MRI data must have been collected at 3T between 1990 and 2020 and must include Double inversion recovery (DIR)/Phase-Sensitive Inversion Recovery (PSIR)/Magnetization Prepared - 2- RApid Gradient Echo Gradient Echo (MP2RAGE) (eventually also high spatial resolution Magnetization Prepared - RApid Gradient Echo (MPRAGE)) for cortical lesion detection.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 27, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical and MRI data of patients with MS or MS mimics (migraine, vasculitis, diabetes, neuromyelitis optica spectrum disorder)
  • MRI data must have been collected at 3T between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection) and DIR/PSIR/MP2RAGE (eventually also high spatial resolution MPRAGE) for cortical lesion detection

Exclusion Criteria:

  • Unavailability of institutional informed consent
  • Unclear diagnosis
  • Other neurological or psychiatric diseases.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Cristina Granziera, Prof. +41 61 265 2525 Cristina.granziera@usb.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369898
Other Study ID Numbers 2020-00765; me20Granziera
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Not Provided
Investigators
Principal Investigator: Cristina Granziera, Prof. Translational Imaging in Neurology, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date August 2020