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Scientists aim to create a universal rulebook for spotting aggressive MS lesions on MRI

NCT ID NCT07705581

Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study looks at how consistently doctors can identify paramagnetic rim lesions (PRLs) on MRI scans of people with multiple sclerosis. PRLs are a sign of more active and aggressive disease. By having experts from 15 centers review the same scans, the researchers aim to create a standard method for spotting these lesions, which could improve diagnosis and monitoring in clinics and future trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a reliable, standardized way to identify aggressive MS lesions on MRI, helping doctors predict disease course and guide treatment decisions.
What could go wrong
This is an observational study using existing scans, so it does not test a new treatment. The results depend on how well raters agree, and differences in MRI machines may still cause inconsistencies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,402 people

The number who actually took part.

Started

Jan 2017

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with confirmed Multiple Sclerosis according to the revised 2017 McDonald Criteria, with previously acquired 3T MRI scans fulfilling NAIMS-PRL criteria and corresponding demographic and clinical data available for retrospective PRL assessment. No new patient recruitment, additional MRI scans, or study-specific interventions will be performed.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Study site

    Oslo, 0372, Norway

  • Amsterdam UMC

    Amsterdam, 1105, Netherlands

  • Charles University and General University Hospital

    Prague, 128 00, Czechia

  • Danish Research Centre for Magnetic Resonance

    Copenhagen, 2650, Denmark

  • IRCCS San Raffaele

    Milan, 20132, Italy

  • Karolinska Neuroimmunology & Multiple Sclerosis (KNIMS) Centre

    Stockholm, 171 77, Sweden

  • Medical University Graz

    Graz, 8036, Austria

  • Medical University of Vienna

    Vienna, 1090, Austria

  • UCL Institute of Neurology

    London, WC1N 3BG, United Kingdom

  • University Hospital Basel

    Basel, 4031, Switzerland

  • University Hospital of Padua

    Padova, 35128, Italy

  • University Medical Center Mainz

    Homburg, 66424, Germany

  • University of Oxford

    Oxford, OX1 2JD, United Kingdom

  • University of Verona

    Verona, 37129, Italy

  • Vall d'Hebron University Hospital

    Barcelona, 08035, Spain

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