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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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04923074
Enrollment
50
Registered
2021-06-11
Start date
2021-07-31
Completion date
2023-07-31
Last updated
2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA Associated Vasculitis

Keywords

peripheral neuropathy

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

Interventions

OTHERdiffusion tensor imaging(DTI) evaluation

DTI is a new kind of MRI technique to evaluate peripheral neuropathy

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy2 yearsb-value is a key technique parameter for DTI, which will decide the quality of DTI image

Secondary

MeasureTime frameDescription
the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).2 yearsBirmingham 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 neuropathy2 yearssCD163, Nfl(neurofilament light polypeptide)and OPN(osteopontin)are new biomarkers of peripheral neuropathy

Countries

China

Contacts

Primary Contactwenjia sun
sunwinjoy@zju.edu.cn86 15869029727
Backup Contactting zhang
zhangtingpumc@163.com86 15888819691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026