Multiple Sclerosis (MS) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Biological
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Nottingham University NHS Trust
RECRUITING
Nottingham
Contact Information
Primary
Ryan Mamun
Ryan.Mamun1@nhs.net
+447490225520
Backup
Rasha Abdelfahim
rasha.abdelfahim@nhs.net
Time Frame
Start Date: 2022-09-03
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
1 - Cross sectional genetics study
International, multicentre study assessing genetic predictors of chronic inflammation in 1000 MS patients with both susceptibility-based brain MRI scan and DNA from peripheral blood samples.The cross-sectional group will include 100 NUH participants who were previously scanned with iron sensitive sequences. These patients will be contacted by their clinical team and invited to participate. Blood samples will be stored in a -80° freezer until all 100 samples have been acquired. At this point, the samples will be shipped to the US for analysis, along with previously acquired MRI scans.
2 - Longitudinal cohort MRI study
The repeat MRI cohort group will be split into two phases. Phase 1: 30 participants who have consented to provide blood samples in the cross sectional genetics study will also be invited to participate by having an additional 7T MRI (funding already secured).~Phase 2: Following completion of phase 1 and securing additional funds we aim to perform more scans to complete our analysis. Exact number of phase 2 participants will be determined from analysis of pilot data.
Related Therapeutic Areas
Sponsors
Collaborators: Johns Hopkins University
Leads: Nottingham University Hospitals NHS Trust

This content was sourced from clinicaltrials.gov