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

A Multi-centric Study of the Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04369898
Enrollment
1051
Registered
2020-04-30
Start date
2010-06-01
Completion date
2023-09-30
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis)

Keywords

cortical lesions, leuco-cortical lesions, central vein sign

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.

Interventions

OTHERImage 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).

OTHERImage 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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity)at Baselinedifferentiation 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 diagnosisat Baselinespecificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)at Baselinedifferentiation 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)
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosisat Baselinesensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026