RecruitingNCT05123443

Longitudinal Assessment of Iron Rims in MS Lesions

Longitudinal Assessment of Iron Rims in White Matter MS Lesions as a Marker of Disability


Sponsor

Nottingham University Hospitals NHS Trust

Enrollment

100 participants

Start Date

Sep 3, 2022

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 16 Years

Inclusion Criteria4

  • Men and women aged above 16 years
  • Clinical diagnosis of MS as per revised McDonald Criteria 2017
  • Existing susceptibility-weighted brain MRI scan
  • Able to provide blood samples

Exclusion Criteria2

  • Unwilling or unable to comply with the requirements of this protocol including the presence of any condition (physical, mental or social) that, in the opinion of the PI, is likely to affect the participants ability to comply with the study protocol.
  • Unable to provide informed consent.

Interventions

BIOLOGICALBlood sample provided

Individuals who consent to provide a blood sample will be included in the cross-sectional genetics study.

DIAGNOSTIC_TEST7-T MRI scan

Individuals who consent to receive an additional 7-T MRI scan will be invited to the Sir Peter Mansfield Imaging Centre. This current MRI will be compared against the baseline 7-T scan performed between 2008 - 2012.


Locations(1)

Nottingham University NHS Trust

Nottingham, United Kingdom

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NCT05123443


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