Clinical Trial

Longitudinal Assessment of Iron Rims in MS Lesions

Recruiting
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Record status
This record was last updated March 12, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
In multiple sclerosis (MS), the presence of white matter lesions surrounded by a rim of iron is suggested to signify a more severe disease course. Iron rim lesions can be detected through their appearance on susceptibility-based brain MRI at either 3-Tesla or 7-Tesla strength. We know that the formation of chronic active lesions is not uniform across MS cohorts so identifying risk factors which predispose individuals to the formation of rim lesions may provide a useful biomarker for clinical progression. One candidate set of risk factors include genetic variants which prevent some MS patients from resolving acute inflammation following their initial wave of inflammatory demyelination at lesion onset. Additionally, only small longitudinal clinical cohorts have reported the evolution of iron rim lesions many years after their initial formation, as well as their link to clinical disability or disease progression. NUH hold 7T-MRI scans of over 100 patients who received a research MRI with iron-sensitive sequences between 2008-2012. We will recruit 100 patients that received brain MRI several years ago to provide blood samples. The blood samples along with the previously acquired MRI scan will be sent to Johns Hopkins University in the US where genotyping studies will be performed to explore whether this genetic variation contributes to the accrual of chronic active rim lesions in MS. Patients who consent to provide blood samples will also have the option to consent to receive an additional 7-Tesla MRI scan which will allow us to compare how rim lesions evolve and whether their presence is correlated with disability. 30 MRI scans will initially be performed as funding for this amount is already secured. Following analysis of the pilot phase 1 data and securing additional funds, we will contact more patients who have already consented to receive the additional MRI to receive the scan
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-11-05.
Status change: Not Yet Recruiting → Recruiting 2026-03-10
Trial Details
NCT Number NCT05123443
Lead Sponsor Nottingham University Hospitals NHS Trust
Collaborators: Johns Hopkins University
Conditions Multiple Sclerosis
Enrollment 100 participants
Start Date 2022-09-03
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12