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

Multiple Sclerosis) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369898
• Other study ID #: 2020-00765; me20Granziera
• Status: Completed
• Start date: June 1, 2010
• Est. completion date: September 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1051
• Est. completion date: September 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• 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).
• 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.

Locations

Country	Name	City	State
Switzerland	Translational Imaging in Neurology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

La Rosa F, Wynen M, Al-Louzi O, Beck ES, Huelnhagen T, Maggi P, Thiran JP, Kober T, Shinohara RT, Sati P, Reich DS, Granziera C, Absinta M, Bach Cuadra M. Cortical lesions, central vein sign, and paramagnetic rim lesions in multiple sclerosis: Emerging ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)	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)	at Baseline
Primary	differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity)	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)	at Baseline
Primary	specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis	specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis	at Baseline
Primary	sensitivity 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	at Baseline

External Links

•   Cortical lesions, central vein sign, and paramagnetic rim lesions in multiple sclerosis: Emerging machine learning techniques and future avenues