the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis

• Conditions: ANCA Associated Vasculitis

• Registration Number: NCT04923074
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-05
• Last Update Submitted: 2021-06-05
• Study First Posted: 2021-06-11
• Last Update Posted: 2021-06-11
• Study Start: 2021-07
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy	2 years	b-value is a key technique parameter for DTI, which will decide the quality of DTI image

Secondary Outcome Measures

Name	Time	Method
the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).	2 years	Birmingham Vasculitis Activity Score (BVAS) is a index of vasculitis disease activity, with the score range 0-63. Fractional anisotropy(FA) and apparent diffusion coefficient(ADC) are two parameters that can be read through DTI image .
the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy	2 years	sCD163, Nfl（neurofilament light polypeptide）and OPN（osteopontin）are new biomarkers of peripheral neuropathy

Trial Locations

Locations (1)

2nd affiliated hospital of Zhejiang University, School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China