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RECRUITING
NCT04106830

Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI. In addition, participants will receive a one-time baseline examination including T1WI, T2WI, FLAIR, and SWI sequences on 7T MRI, as well as PET-MRI.

Official title: Prospective Cohort Study of cLinical and Imaging Patterns of neUroinflammation disEases (CLUE)

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2019-01-01

Completion Date

2028-12-31

Last Updated

2026-06-15

Healthy Volunteers

Yes

Interventions

DRUG

Intravenous steroid

This study does not limit treatment methods. During the acute stage, patients commonly receive high-dose intravenous methylprednisolone (1g daily for 3-5 days). For severe or refractory cases, plasma exchange (PLEX) or intravenous immunoglobulin (IVIG) may be added. For PACNS, cyclophosphamide is added to steroids as standard induction. During remission, immunomodulatory or immunosuppressive therapies vary by disease: for MS, DMTs such as ocrelizumab or natalizumab; for NMOSD, rituximab (500mg on day 1 and 15, then every 6 months), eculizumab, or satralizumab; for MOGAD, azathioprine, mycophenolate mofetil, or rituximab but only for relapsing patients; for PACNS, azathioprine or mycophenolate mofetil for 12-18 months after cyclophosphamide; for AE, rituximab or cyclophosphamide for refractory cases, with maintenance only for relapsing forms.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China