RecruitingNot Applicable

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

China1,000 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range

16 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The brain structural change over time between the baseline MRI and the follow-up MRIs

Timeframe: On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

The spinal cord change over time between the baseline MRI and the follow-up MRIs.

Timeframe: On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

The functional change over time between the baseline MRI and the follow-up MRIs.

Timeframe: On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

Trial details

NCT IDNCT04106830

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Yaou Liu, PhD

+86 1059975396 yaouliu80@163.com

View on ClinicalTrials.gov More NMO Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

16 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The brain structural change over time between the baseline MRI and the follow-up MRIs

Timeframe: On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

The spinal cord change over time between the baseline MRI and the follow-up MRIs.

Timeframe: On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

The functional change over time between the baseline MRI and the follow-up MRIs.

Timeframe: On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later