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

ANCA Associated Vasculitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923074
• Other study ID #: 2020-162
• Status: Recruiting
• Start date: July 2021
• Est. completion date: July 2023

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: wenjia sun
• Phone: 86 15869029727
• Email: sunwinjoy[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ANCA Associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Peripheral Nervous System Diseases
• Vasculitis

Intervention

Other:
• diffusion tensor imaging(DTI) evaluation
DTI is a new kind of MRI technique to evaluate peripheral neuropathy

Locations

Country	Name	City	State
China	2nd affiliated hospital of Zhejiang University, School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy	b-value is a key technique parameter for DTI, which will decide the quality of DTI image	2 years
Secondary	the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).	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 .	2 years
Secondary	the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy	sCD163, Nfl(neurofilament light polypeptide)and OPN(osteopontin)are new biomarkers of peripheral neuropathy	2 years