Multiple Sclerosis Clinical Trial
— ULTIMSOfficial title:
Multiple Sclerosis Lesion Characterization on Ultra-high-field MRI: Comparative Pilot Study of 9.4 vs 7 vs 3 Tesla
Verified date | March 2024 |
Source | Zuyderland Medisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The MRI scan is one of the most important tools for diagnosing multiple sclerosis (MS) and for monitoring disease progression and medication effects. Increasingly strong MRI magnets (higher field strength) enable us to see abnormalities in the brain in greater detail. On the other hand, it poses challenges because these higher field strength MRIs are more sensitive to disturbances, for example due to motion, including physiological motion such as breathing and swallowing. In current practice, field strengths of up to 3 Tesla are common. The aim of this study is to compare scanning at field strengths of 3 Tesla in 10 MS patients at two different moments (baseline and 6 months) with scanning at field strengths that are higher, namely 7 and 9.4 Tesla, in order to identify the advantages and disadvantages. With the further development of this technique, the investigators may be able to make a better diagnosis in the future and detect subtle changes in the course of the disease more quickly in order to optimize treatments.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | August 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Relapsing remitting MS patients (according to the 2017 McDonald criteria) - Age 18-65 years - New brain MRI lesion in the past 15 months. Exclusion Criteria: - Non-compatible implanted material/devices - Not being able to lie flat long enough (for the MRI) because of another medical condition |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland MC | Geleen | Limburg |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum | Scannexus |
Netherlands,
Absinta 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. — View Citation
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Sati P. Diagnosis of multiple sclerosis through the lens of ultra-high-field MRI. J Magn Reson. 2018 Jun;291:101-109. doi: 10.1016/j.jmr.2018.01.022. Epub 2018 Apr 26. — View Citation
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Trattnig S, Bogner W, Gruber S, Szomolanyi P, Juras V, Robinson S, Zbyn S, Haneder S. Clinical applications at ultrahigh field (7 T). Where does it make the difference? NMR Biomed. 2016 Sep;29(9):1316-34. doi: 10.1002/nbm.3272. Epub 2015 Mar 12. — View Citation
van der Kolk AG, Hendrikse J, Zwanenburg JJ, Visser F, Luijten PR. Clinical applications of 7 T MRI in the brain. Eur J Radiol. 2013 May;82(5):708-18. doi: 10.1016/j.ejrad.2011.07.007. Epub 2011 Sep 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detected white- and grey-matter lesions | Given that the present study is a pilot, descriptive statistics will be employed to identify important trends between field strengths, evaluating the number of lesions that can be identified in white as well as grey matter, in what proportion of lesions a perivenous localization can be identified | 6 months | |
Secondary | Image quality parameters (signal-to-noise and contrast-to-noise ratios) | 6 months |
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