Active — Not RecruitingNot Applicable

Validation and Standardization of Paramagnetic Rim Lesion (PRL) Identification in Multiple Sclerosis Across MAGNIMS Centers

Austria, Czechia, Denmark1,402 participantsStarted 2017-01-01

Plain-language summary

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. Paramagnetic rim lesions (PRLs) are a subtype of chronic active MS lesions showing an iron-laden inflammatory rim on susceptibility-sensitive MRI. PRLs mark a more aggressive disease course and have recently been incorporated, together with the central vein sign, into the updated diagnostic criteria for MS. Before PRLs can be used reliably in multicenter clinical practice and trials, the way they are identified must be shown to be consistent across different centers, raters, and scanners. This is a retrospective, multicenter, observational validation study. Using previously acquired 3-Tesla brain MRI scans from MS patients across 15 MAGNIMS centers, expert raters count PRLs according to the NAIMS consensus definitions. The study measures how consistently PRLs are identified between centers, raters, and scanners (inter-rater, inter-center, and inter-scanner agreement), using statistical methods such as the intraclass correlation coefficient (ICC) and Bland-Altman analysis. Where systematic sources of disagreement are found, the PRL definitions are refined through a structured Delphi consensus process and re-tested on an independent set of scans. The goal is to standardize PRL identification and provide an evidence-based basis for consistent, reproducible PRL assessment to support future multicenter studies. No new patients are recruited and no new scans or biological samples are collected; only pre-existing, de-identified imaging and clinical data are used.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with confirmed diagnosis of Multiple Sclerosis (MS) according to the revised 2017 McDonald Criteria. * Aged 18 years or older at the time of MRI scan. * Previously acquired 3T MRI scans performed according to NAIMS-PRL criteria, including 3D-FLAIR, SWI, and post-Gd 2D/3D T1-weighted sequences. * MRI resolution according to NAIMS criteria: submillimeter in-plane resolution ≤0.9 mm; 2D acquisition with slice thickness ≤3 mm; 3D acquisition with ≤2-mm isotropic or higher resolution. * Patients must have already provided consent for research use of their MRI scans and corresponding clinical data. Exclusion Criteria: * 3T MRI data not meeting all inclusion criteria. * MRI scans with artifacts, poor image quality, or other limitations preventing reliable PRL assessment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rated number of paramagnetic rim lesions (PRLs) per MRI scan and per rater

Timeframe: Baseline

Trial details

NCT IDNCT07705581

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12

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