跳至主要内容
临床试验/NCT06196931
NCT06196931尚未招募不适用

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

Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
UWDRS scales

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

UWDRS scales

时间窗: Before and 4 weeks after treatment

It is used to evaluate the changes of patients' nervous system symptoms

24h urine copper

时间窗: Before and 4 weeks after treatment

used to evaluate the changes of patients' nervous system symptoms

次要结局

  • Semi-quantitative brain MRI score(Before de-copper treatment)
  • ALT, AST and other liver function test(Before and 4 weeks after treatment)

研究者

发起方
Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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