Multiple SclerosisNCT07705581
Validation and Standardization of Paramagnetic Rim Lesion (PRL) Identification in Multiple Sclerosis Across MAGNIMS Centers
An observational study of Multiple Sclerosis, run by IRCCS San Raffaele at 15 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 1,402 participants
- Where
- 15 sitesin 11 countries
- Study dates
- 1 Jan 2017to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 3T MRI data not meeting all inclusion criteria.
- MRI scans with artifacts, poor image quality, or other limitations preventing reliable PRL assessment.
Trial locations and contacts
15 sites in 11 countries.
15 sites in 11 countries
Italy3 sites
IRCCS San Raffaele
Milan, 20132
University Hospital of Padua
Padova, 35128
University of Verona
Verona, 37129
Austria2 sites
Medical University Graz
Graz, 8036
Medical University of Vienna
Vienna, 1090
United Kingdom2 sites
UCL Institute of Neurology
London, WC1N 3BG
University of Oxford
Oxford, OX1 2JD
Czechia1 site
Charles University and General University Hospital
Prague, 128 00
Sweden1 site
Karolinska Neuroimmunology & Multiple Sclerosis (KNIMS) Centre
Stockholm, 171 77
About this study
Official title: Validation and Standardization of Paramagnetic Rim Lesion (PRL) Identification in Multiple Sclerosis Across MAGNIMS Centers - From Scientific Setting Towards Clinical Applicability
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.
Read the detailed description
Design: Retrospective, multicenter, observational validation study coordinated by IRCCS Ospedale San Raffaele (Milan, Italy) within the MAGNIMS network.
Data source: A pool of previously acquired 3T brain MRI scans fulfilling NAIMS-PRL acquisition criteria (3D-FLAIR, SWI, post-gadolinium 2D/3D T1-weighted; submillimeter in-plane resolution) is available across 15 MAGNIMS centers. A preliminary survey identified 1402 eligible scans. To participate in the study, each MAGNIMS center is required to contribute scans from a minimum of 30 patients and to have at least one expert rater with clinical or research experience in PRL evaluation. From this pool, two selected datasets of 150 scans each, corresponding to 10 randomly selected scans per center per scanner, are drawn for evaluation. The selected datasets are balanced across MS phenotype, age, and lesion load.
Evaluation procedure: Phase 1 - First evaluation: Selected Dataset 1 is rated for PRLs by at least one expert rater from each participating MAGNIMS center, applying the NAIMS-PRL criteria. Inter-rater, inter-center, and intra-center reproducibility of PRL counts is assessed using intraclass correlation coefficient and Bland-Altman analysis by the coordinating center together with the Department of Neurology, Medical University of Vienna. Phase 2 - Disagreement analysis: Sources of disagreement between expert raters are identified at the level of individual PRL designations on the MRI images. Phase 3 - Refinement and Delphi consensus: If consistent sources of disagreement are identified, proposed refinements to the PRL definitions are translated into operationalized consensus statements and ratified through an electronic Delphi survey using a 5-point Likert scale. Consensus requires at least 75% agreement, with a minimum 80% response rate per round. Phase 4 - Second evaluation: The refined criteria are re-tested on Selected Dataset 2 by the same expert raters, with repeated ICC and Bland-Altman analysis. If excellent reproducibility, defined as ICC ≥0.90, is reached, the process is complete; otherwise, Phases 2 to 4 are repeated.
Clinical correlations: Mandatory clinical data, including demographics, MS phenotype, EDSS, and disease duration, and, where available, optional measures, including Timed 25-Foot Walk and 9-Hole Peg Test, are integrated to explore associations between PRL burden and clinical disability.
Data handling: All imaging and clinical data are de-identified, either anonymized or, where agreed in the Data Transfer Agreement, pseudonymized, before transfer to the coordinating center. MRI data in NIfTI format undergo defacing using fsl_deface from the FMRIB Software Library. No new recruitment, MRI scans, biological samples, or study-specific interventions are performed. Retrospective data acquired between January 2017 and November 2025 are used.
- Conditions
- Multiple Sclerosis
- Keywords
- Paramagnetic Rim Lesions, Chronic Active Lesions, Magnetic Resonance Imaging, Susceptibility-Weighted Imaging, Quantitative Susceptibility Mapping, Imaging Biomarker, Multiple Sclerosis, MAGNIMS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS patients with pre-acquired 3T MRI scans | Retrospective cohort of adult patients with confirmed Multiple Sclerosis according to the revised 2017 McDonald Criteria, with pre-acquired 3T MRI scans fulfilling NAIMS-PRL criteria and corresponding demographic and clinical data available for research use. No new patient recruitment, MRI scans, or study-specific interventions will be performed. MRI data will be retrospectively assessed for paramagnetic rim lesions to evaluate the reliability and consistency of PRL identification across MAGNIMS centers, raters, and scanners. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rated number of paramagnetic rim lesions (PRLs) per MRI scan and per rater
Number of paramagnetic rim lesions (PRLs) identified on each pre-acquired 3T MRI scan by each rater, according to NAIMS-PRL criteria, to evaluate the consistency and reliability of PRL identification across MAGNIMS centers, raters, and scanners.
Measured: Baseline
Secondary outcomes (1)
Correlation between PRL burden and clinical characteristics
Assessment of potential correlations between paramagnetic rim lesion (PRL) burden and clinical characteristics, including Expanded Disability Status Scale (EDSS), MS phenotype, disease duration, and, if available, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Test (9HPT).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jan 2017
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria A. Rocca, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705581
- Sponsor's protocol ID
- PRL MAGNIMS MS
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be made publicly available. The study involves the transfer and analysis of anonymized or pseudonymized demographic, clinical, and MRI data, according to the applicable Data Transfer Agreements, for the specific purposes of the MAGNIMS PRL validation study.
Publications
Dal-Bianco A, Oh J, Sati P, Absinta M. Chronic active lesions in multiple sclerosis: classification, terminology, and clinical significance. Ther Adv Neurol Disord. 2024 Dec 19;17:17562864241306684. doi: 10.1177/17562864241306684. eCollection 2024.
PubMed 39711984Koch-Henriksen N, Sorensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol. 2010 May;9(5):520-32. doi: 10.1016/S1474-4422(10)70064-8.
PubMed 20398859Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.
PubMed 32511687Tur C, Carbonell-Mirabent P, Cobo-Calvo A, Otero-Romero S, Arrambide G, Midaglia L, Castillo J, Vidal-Jordana A, Rodriguez-Acevedo B, Zabalza A, Galan I, Nos C, Salerno A, Auger C, Pareto D, Comabella M, Rio J, Sastre-Garriga J, Rovira A, Tintore M, Montalban X. Association of Early Progression Independent of Relapse Activity With Long-term Disability After a First Demyelinating Event in Multiple Sclerosis. JAMA Neurol. 2023 Feb 1;80(2):151-160. doi: 10.1001/jamaneurol.2022.4655.
PubMed 36534392Cagol A, Benkert P, Melie-Garcia L, Schaedelin SA, Leber S, Tsagkas C, Barakovic M, Galbusera R, Lu PJ, Weigel M, Ruberte E, Radue EW, Yaldizli O, Oechtering J, Lorscheider J, D'Souza M, Fischer-Barnicol B, Muller S, Achtnichts L, Vehoff J, Disanto G, Findling O, Chan A, Salmen A, Pot C, Bridel C, Zecca C, Derfuss T, Lieb JM, Remonda L, Wagner F, Vargas MI, Du Pasquier RA, Lalive PH, Pravata E, Weber J, Cattin PC, Absinta M, Gobbi C, Leppert D, Kappos L, Kuhle J, Granziera C. Association of Spinal Cord Atrophy and Brain Paramagnetic Rim Lesions With Progression Independent of Relapse Activity in People With MS. Neurology. 2024 Jan 9;102(1):e207768. doi: 10.1212/WNL.0000000000207768. Epub 2023 Dec 13.
PubMed 38165377Dal-Bianco A, Grabner G, Kronnerwetter C, Weber M, Kornek B, Kasprian G, Berger T, Leutmezer F, Rommer PS, Trattnig S, Lassmann H, Hametner S. Long-term evolution of multiple sclerosis iron rim lesions in 7 T MRI. Brain. 2021 Apr 12;144(3):833-847. doi: 10.1093/brain/awaa436.
PubMed 33484118Dal-Bianco A, Grabner G, Kronnerwetter C, Weber M, Hoftberger R, Berger T, Auff E, Leutmezer F, Trattnig S, Lassmann H, Bagnato F, Hametner S. Slow expansion of multiple sclerosis iron rim lesions: pathology and 7 T magnetic resonance imaging. Acta Neuropathol. 2017 Jan;133(1):25-42. doi: 10.1007/s00401-016-1636-z. Epub 2016 Oct 27.
PubMed 27796537Absinta M, Sati P, Schindler M, Leibovitch EC, Ohayon J, Wu T, Meani A, Filippi M, Jacobson S, Cortese IC, Reich DS. Persistent 7-tesla phase rim predicts poor outcome in new multiple sclerosis patient lesions. J Clin Invest. 2016 Jul 1;126(7):2597-609. doi: 10.1172/JCI86198. Epub 2016 Jun 6.
PubMed 27270171Absinta M, Sati P, Masuzzo F, Nair G, Sethi V, Kolb H, Ohayon J, Wu T, Cortese ICM, Reich DS. Association of Chronic Active Multiple Sclerosis Lesions With Disability In Vivo. JAMA Neurol. 2019 Dec 1;76(12):1474-1483. doi: 10.1001/jamaneurol.2019.2399.
PubMed 31403674Calvi A, Clarke MA, Prados F, Chard D, Ciccarelli O, Alberich M, Pareto D, Rodriguez Barranco M, Sastre-Garriga J, Tur C, Rovira A, Barkhof F. Relationship between paramagnetic rim lesions and slowly expanding lesions in multiple sclerosis. Mult Scler. 2023 Mar;29(3):352-362. doi: 10.1177/13524585221141964. Epub 2022 Dec 14.
PubMed 36515487Elliott C, Arnold DL, Chen H, Ke C, Zhu L, Chang I, Cahir-McFarland E, Fisher E, Zhu B, Gheuens S, Scaramozza M, Beynon V, Franchimont N, Bradley DP, Belachew S. Patterning Chronic Active Demyelination in Slowly Expanding/Evolving White Matter MS Lesions. AJNR Am J Neuroradiol. 2020 Sep;41(9):1584-1591. doi: 10.3174/ajnr.A6742. Epub 2020 Aug 20.
PubMed 32819894Reeves JA, Mohebbi M, Wicks T, Salman F, Bartnik A, Jakimovski D, Bergsland N, Schweser F, Weinstock-Guttman B, Dwyer MG, Zivadinov R. Paramagnetic rim lesions predict greater long-term relapse rates and clinical progression over 10 years. Mult Scler. 2024 Apr;30(4-5):535-545. doi: 10.1177/13524585241229956. Epub 2024 Feb 17.
PubMed 38366920Ng Kee Kwong KC, Mollison D, Meijboom R, York EN, Kampaite A, Thrippleton MJ, Chandran S, Waldman AD. The prevalence of paramagnetic rim lesions in multiple sclerosis: A systematic review and meta-analysis. PLoS One. 2021 Sep 8;16(9):e0256845. doi: 10.1371/journal.pone.0256845. eCollection 2021.
PubMed 34495999Hemond CC, Reich DS, Dundamadappa SK. Paramagnetic Rim Lesions in Multiple Sclerosis: Comparison of Visualization at 1.5-T and 3-T MRI. AJR Am J Roentgenol. 2022 Jul;219(1):120-131. doi: 10.2214/AJR.21.26777. Epub 2021 Dec 1.
PubMed 34851712Bagnato F, Sati P, Hemond CC, Elliott C, Gauthier SA, Harrison DM, Mainero C, Oh J, Pitt D, Shinohara RT, Smith SA, Trapp B, Azevedo CJ, Calabresi PA, Henry RG, Laule C, Ontaneda D, Rooney WD, Sicotte NL, Reich DS, Absinta M. Imaging chronic active lesions in multiple sclerosis: a consensus statement. Brain. 2024 Sep 3;147(9):2913-2933. doi: 10.1093/brain/awae013.
PubMed 38226694
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Standardization of Paramagnetic Rim Lesion (PRL) Identification in Multiple Sclerosis Across MAGNIMS Centers - From Scientific Setting Towards Clinical Applicability
- ClinicalTrials.gov ID
- NCT07705581
- Acronym / sponsor ID
- PRL MAGNIMS MS
- Conditions
- Multiple Sclerosis
- Keywords
- Paramagnetic Rim Lesions, Chronic Active Lesions, Magnetic Resonance Imaging, Susceptibility-Weighted Imaging, Quantitative Susceptibility Mapping, Imaging Biomarker, Multiple Sclerosis, MAGNIMS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,402 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: Retrospective, multicenter, observational validation study coordinated by IRCCS Ospedale San Raffaele (Milan, Italy) within the MAGNIMS network.
Data source: A pool of previously acquired 3T brain MRI scans fulfilling NAIMS-PRL acquisition criteria (3D-FLAIR, SWI, post-gadolinium 2D/3D T1-weighted; submillimeter in-plane resolution) is available across 15 MAGNIMS centers. A preliminary survey identified 1402 eligible scans. To participate in the study, each MAGNIMS center is required to contribute scans from a minimum of 30 patients and to have at least one expert rater with clinical or research experience in PRL evaluation. From this pool, two selected datasets of 150 scans each, corresponding to 10 randomly selected scans per center per scanner, are drawn for evaluation. The selected datasets are balanced across MS phenotype, age, and lesion load.
Evaluation procedure: Phase 1 - First evaluation: Selected Dataset 1 is rated for PRLs by at least one expert rater from each participating MAGNIMS center, applying the NAIMS-PRL criteria. Inter-rater, inter-center, and intra-center reproducibility of PRL counts is assessed using intraclass correlation coefficient and Bland-Altman analysis by the coordinating center together with the Department of Neurology, Medical University of Vienna. Phase 2 - Disagreement analysis: Sources of disagreement between expert raters are identified at the level of individual PRL designations on the MRI images. Phase 3 - Refinement and Delphi consensus: If consistent sources of disagreement are identified, proposed refinements to the PRL definitions are translated into operationalized consensus statements and ratified through an electronic Delphi survey using a 5-point Likert scale. Consensus requires at least 75% agreement, with a minimum 80% response rate per round. Phase 4 - Second evaluation: The refined criteria are re-tested on Selected Dataset 2 by the same expert raters, with repeated ICC and Bland-Altman analysis. If excellent reproducibility, defined as ICC ≥0.90, is reached, the process is complete; otherwise, Phases 2 to 4 are repeated.
Clinical correlations: Mandatory clinical data, including demographics, MS phenotype, EDSS, and disease duration, and, where available, optional measures, including Timed 25-Foot Walk and 9-Hole Peg Test, are integrated to explore associations between PRL burden and clinical disability.
Data handling: All imaging and clinical data are de-identified, either anonymized or, where agreed in the Data Transfer Agreement, pseudonymized, before transfer to the coordinating center. MRI data in NIfTI format undergo defacing using fsl_deface from the FMRIB Software Library. No new recruitment, MRI scans, biological samples, or study-specific interventions are performed. Retrospective data acquired between January 2017 and November 2025 are used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients with pre-acquired 3T MRI scans | – | –Retrospective cohort of adult patients with confirmed Multiple Sclerosis according to the revised 2017 McDonald Criteria, with pre-acquired 3T MRI scans fulfilling NAIMS-PRL criteria and corresponding demographic and clinical data available for research use. No new patient recruitment, MRI scans, or study-specific interventions will be performed. MRI data will be retrospectively assessed for paramagnetic rim lesions to evaluate the reliability and consistency of PRL identification across MAGNIMS centers, raters, and scanners. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 3T MRI data not meeting all inclusion criteria.
- MRI scans with artifacts, poor image quality, or other limitations preventing reliable PRL assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rated number of paramagnetic rim lesions (PRLs) per MRI scan and per rater
Time frame: Baseline
Number of paramagnetic rim lesions (PRLs) identified on each pre-acquired 3T MRI scan by each rater, according to NAIMS-PRL criteria, to evaluate the consistency and reliability of PRL identification across MAGNIMS centers, raters, and scanners.
1 secondary outcome
Correlation between PRL burden and clinical characteristics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 39711984Dal-Bianco A, Oh J, Sati P, Absinta M. Chronic active lesions in multiple sclerosis: classification, terminology, and clinical significance. Ther Adv Neurol Disord. 2024 Dec 19;17:17562864241306684. doi: 10.1177/17562864241306684. eCollection 2024.
- Background: PubMed 20398859Koch-Henriksen N, Sorensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol. 2010 May;9(5):520-32. doi: 10.1016/S1474-4422(10)70064-8.
- Background: PubMed 32511687Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.
- Background: PubMed 36534392Tur C, Carbonell-Mirabent P, Cobo-Calvo A, Otero-Romero S, Arrambide G, Midaglia L, Castillo J, Vidal-Jordana A, Rodriguez-Acevedo B, Zabalza A, Galan I, Nos C, Salerno A, Auger C, Pareto D, Comabella M, Rio J, Sastre-Garriga J, Rovira A, Tintore M, Montalban X. Association of Early Progression Independent of Relapse Activity With Long-term Disability After a First Demyelinating Event in Multiple Sclerosis. JAMA Neurol. 2023 Feb 1;80(2):151-160. doi: 10.1001/jamaneurol.2022.4655.
- Background: PubMed 38165377Cagol A, Benkert P, Melie-Garcia L, Schaedelin SA, Leber S, Tsagkas C, Barakovic M, Galbusera R, Lu PJ, Weigel M, Ruberte E, Radue EW, Yaldizli O, Oechtering J, Lorscheider J, D'Souza M, Fischer-Barnicol B, Muller S, Achtnichts L, Vehoff J, Disanto G, Findling O, Chan A, Salmen A, Pot C, Bridel C, Zecca C, Derfuss T, Lieb JM, Remonda L, Wagner F, Vargas MI, Du Pasquier RA, Lalive PH, Pravata E, Weber J, Cattin PC, Absinta M, Gobbi C, Leppert D, Kappos L, Kuhle J, Granziera C. Association of Spinal Cord Atrophy and Brain Paramagnetic Rim Lesions With Progression Independent of Relapse Activity in People With MS. Neurology. 2024 Jan 9;102(1):e207768. doi: 10.1212/WNL.0000000000207768. Epub 2023 Dec 13.
- Background: PubMed 33484118Dal-Bianco A, Grabner G, Kronnerwetter C, Weber M, Kornek B, Kasprian G, Berger T, Leutmezer F, Rommer PS, Trattnig S, Lassmann H, Hametner S. Long-term evolution of multiple sclerosis iron rim lesions in 7 T MRI. Brain. 2021 Apr 12;144(3):833-847. doi: 10.1093/brain/awaa436.
- Background: PubMed 27796537Dal-Bianco A, Grabner G, Kronnerwetter C, Weber M, Hoftberger R, Berger T, Auff E, Leutmezer F, Trattnig S, Lassmann H, Bagnato F, Hametner S. Slow expansion of multiple sclerosis iron rim lesions: pathology and 7 T magnetic resonance imaging. Acta Neuropathol. 2017 Jan;133(1):25-42. doi: 10.1007/s00401-016-1636-z. Epub 2016 Oct 27.
- Background: PubMed 27270171Absinta M, Sati P, Schindler M, Leibovitch EC, Ohayon J, Wu T, Meani A, Filippi M, Jacobson S, Cortese IC, Reich DS. Persistent 7-tesla phase rim predicts poor outcome in new multiple sclerosis patient lesions. J Clin Invest. 2016 Jul 1;126(7):2597-609. doi: 10.1172/JCI86198. Epub 2016 Jun 6.
- Background: PubMed 31403674Absinta M, Sati P, Masuzzo F, Nair G, Sethi V, Kolb H, Ohayon J, Wu T, Cortese ICM, Reich DS. Association of Chronic Active Multiple Sclerosis Lesions With Disability In Vivo. JAMA Neurol. 2019 Dec 1;76(12):1474-1483. doi: 10.1001/jamaneurol.2019.2399.
- Background: PubMed 36515487Calvi A, Clarke MA, Prados F, Chard D, Ciccarelli O, Alberich M, Pareto D, Rodriguez Barranco M, Sastre-Garriga J, Tur C, Rovira A, Barkhof F. Relationship between paramagnetic rim lesions and slowly expanding lesions in multiple sclerosis. Mult Scler. 2023 Mar;29(3):352-362. doi: 10.1177/13524585221141964. Epub 2022 Dec 14.
- Background: PubMed 32819894Elliott C, Arnold DL, Chen H, Ke C, Zhu L, Chang I, Cahir-McFarland E, Fisher E, Zhu B, Gheuens S, Scaramozza M, Beynon V, Franchimont N, Bradley DP, Belachew S. Patterning Chronic Active Demyelination in Slowly Expanding/Evolving White Matter MS Lesions. AJNR Am J Neuroradiol. 2020 Sep;41(9):1584-1591. doi: 10.3174/ajnr.A6742. Epub 2020 Aug 20.
- Background: PubMed 38366920Reeves JA, Mohebbi M, Wicks T, Salman F, Bartnik A, Jakimovski D, Bergsland N, Schweser F, Weinstock-Guttman B, Dwyer MG, Zivadinov R. Paramagnetic rim lesions predict greater long-term relapse rates and clinical progression over 10 years. Mult Scler. 2024 Apr;30(4-5):535-545. doi: 10.1177/13524585241229956. Epub 2024 Feb 17.
- Individual participant dataSharing planned: No. Individual participant-level data will not be made publicly available. The study involves the transfer and analysis of anonymized or pseudonymized demographic, clinical, and MRI data, according to the applicable Data Transfer Agreements, for the specific purposes of the MAGNIMS PRL validation study.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by IRCCS San Raffaele at 15 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Austria, United Kingdom, Czechia, Denmark and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rated number of paramagnetic rim lesions (PRLs) per MRI scan and per rater (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07705581, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.