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

NCT04106830 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Yaou Liu, PhD · Beijing Tiantan Hospital

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106830 on ClinicalTrials.gov