Observational study of neuroinflammation diseases in China
Prospective Cohort Study of CLinical and Imaging Patterns of NeUroinflammation DisEases (CLUE)
This study is trying to see how brain and spinal cord changes in people with neuroinflammatory diseases can help us understand their condition better over a year of MRI scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Drugs / interventions | Rituximab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04106830 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate structural and functional changes in the brain and spinal cord of patients with neuroinflammatory and demyelination diseases using advanced MRI techniques. Participants will undergo various MRI scans, including double inversion recovery and diffusion kurtosis imaging, over a one-year follow-up period. The goal is to better understand the inflammatory environment and its impact on disease progression and disability. This observational approach will help identify key biomarkers and imaging characteristics associated with these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16-75 diagnosed with neuroinflammatory and demyelination diseases.
Not a fit: Patients who cannot undergo MRI due to contraindications or those currently participating in blinded clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and monitoring strategies for patients with neuroinflammatory diseases.
How similar studies have performed: Other studies utilizing advanced MRI techniques have shown promise in understanding neuroinflammatory diseases, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 16-75 * Diagnosis of neuroinflammatory and demyelination disease * Availability of demographic and clinical data at the time disease onset * Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years. Exclusion Criteria: * Patients for whom MRI is contra-indicated * Patients included in an ongoing clinical trial where the product is blinded
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yaou Liu, PhD — Beijing Tiantan Hospital
- Study coordinator: Yaou Liu, PhD
- Email: yaouliu80@163.com
- Phone: +86 1059975396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.