Clinical trial NCT04369898: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis)
Keywords: cortical lesions
leuco-cortical lesions
central vein sign
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 1051
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)
timeFrame: at Baseline
measure: differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity)
timeFrame: at Baseline
measure: specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
timeFrame: at Baseline
measure: sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
timeFrame: at Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Translational Imaging in Neurology, University Hospital Basel
Study officials:
affiliation: Translational Imaging in Neurology, University Hospital Basel
name: Cristina Granziera, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.