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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04923074

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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；
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；
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

Condition or Disease	Intervention/Treatment	Phase
ANCA Associated Vasculitis	Other: diffusion tensor imaging(DTI) evaluation

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd affiliated hospital of Zhejiang University, School of Medicine	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Jing Xue, 2nd affiliated hospital of Zhejiang University, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04923074

Other Study ID Numbers:

2020-162

First Posted:

Jun 11, 2021

Last Update Posted:

Jun 11, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

peripheral neuropathy

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Vasculitis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study Results

No Results Posted as of Jun 11, 2021