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

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

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

Study Overview

• Status: Recruiting
• Conditions: ANCA Associated Vasculitis
• Intervention / Treatment: Other: diffusion tensor imaging(DTI) evaluation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: wenjia sun; Phone Number: 86 15869029727; Email: sunwinjoy@zju.edu.cn
• Study Contact Backup: Name: ting zhang; Phone Number: 86 15888819691; Email: zhangtingpumc@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd affiliated hospital of Zhejiang University, School of Medicine
      • Contact: wenjia sun; Phone Number: 86 15869029727; Email: sunwinjoy@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult AAV patients with peripheral neuropathy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DTI group; the patient in this group will receive DTI evaluation	Other: diffusion tensor imaging(DTI) evaluation; DTI is a new kind of MRI technique to evaluate peripheral neuropathy
routine group; the patient in this group will receive routine evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Jing Xue, 2nd affiliated hospital of Zhejiang University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 5, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: peripheral neuropathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neuromuscular Diseases; Systemic Vasculitis; Peripheral Nervous System Diseases; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Other Study ID Numbers: 2020-162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No