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

NCT04369898 | Completed

• 1 other identifier: 2020-00765; me20Granziera
• Study Type: observational
• Target: 1,051
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis)

Keywords

cortical lesions; leuco-cortical lesions; central vein sign

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

Image analysis/ Central vein detection OTHER

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 OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unavailability of institutional informed consent
• Unclear diagnosis
• Other neurological or psychiatric diseases.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Translational Imaging in Neurology, University Hospital Basel

Basel, 4031, Switzerland

Location

Related 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 machine learning techniques and future avenues. Neuroimage Clin. 2022;36:103205. doi: 10.1016/j.nicl.2022.103205. Epub 2022 Sep 24.

  PMID: 36201950 RESULT

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cristina Granziera, Prof.

  Translational Imaging in Neurology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: June 1, 2010
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

CH (1)