NCT05123443 Longitudinal Assessment of Iron Rims in MS Lesions
| NCT ID | NCT05123443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nottingham University Hospitals NHS Trust |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-09-03 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-09-03 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05123443 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05123443 currently recruiting?
Yes, NCT05123443 is actively recruiting participants. Contact the research team at Ryan.Mamun1@nhs.net for enrollment information.
Where is the NCT05123443 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT05123443 clinical trial?
NCT05123443 is sponsored by Nottingham University Hospitals NHS Trust. The trial plans to enroll 100 participants.
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