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Not yet recruiting NCT06196931

Clinical Value of DWI-ADC Matching in the Short-term Prognosis of Wilson's Disease

Observational Hepatolenticular Degeneration; Wilson

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatolenticular Degeneration; Wilson. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

In earlier studies, it was found that patients of Wilson disease with new diagnosed who only has neurological symptoms often had DWI hyper-intensity in brain MRI, which was more common in putamen and midbrain, indicating that the disease was in the acute stage. However, many patients had ADC hyper-intensity or hypo-intensity at the same time, and the two different signals represented different disease processes from an imaging perspective. The former indicating T2 penetration effect, and the latter represents diffusion limitation, which indicating the presence of local inflammation, edema, etc. Whether the signal changes of these two different matching modes have guiding significance for the early de-copper treatment for WD, one is the core point of our study. We hope to exploring the predictive value about DWI-ACD signal matching for symptoms changes in the earlier time of de-copper treatment through this study.

Primary outcome measures

  • UWDRS scales [Time frame: Before and 4 weeks after treatment]
  • 24h urine copper [Time frame: Before and 4 weeks after treatment]
Secondary outcome measures (2)
  • Semi-quantitative brain MRI score [Time frame: Before de-copper treatment]
  • ALT, AST and other liver function test [Time frame: Before and 4 weeks after treatment]

Eligibility criteria

Inclusion criteria

  • Patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time;
  • Patients who accept de-copper treatment in hospitalization for 4 weeks or more.

Exclusion criteria

  • Patients who only with liver injury;
  • Severe complications;
  • Combined with other diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The affiliated hospital of Institute of Neurology in Anhui University of Chinese Medicine — Hefei

Identifiers

NCT: NCT06196931 · AHnkyy20231020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗