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临床试验/NCT04923074
NCT04923074Unknown不适用

the Application of Diffusion Tensor Imaging(DTI) in the Evaluation of Peripheral Neuropathy in Anti-neutrophil Cytoplasmic Antibodies Associated Vasculitis(AAV)

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy；
  2. On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI；
  3. The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA； (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •age between 18-80 years old；
  • •must fulfill 2012 criteria of ANCA associated vasculitis
  • •presented with peripheral neuropathy diagnosed by specialists

排除标准

  • •the ANCA associated vasculitis is already in the stable stage after treatments
  • •any vital organ dysfunction
  • •active infection or cancer
  • •can not finish DTI scan

结局指标

主要结局

To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy

时间窗: 2 years

b-value is a key technique parameter for DTI, which will decide the quality of DTI image

次要结局

  • the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).(2 years)
  • the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy(2 years)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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