Usefulness of Multi-parametric, Quantitative MR Imaging for Staging of Hepatic Fibrosis in the Patients With Chronic Hepatitis

• Conditions: Liver Fibrosis

• Registration Number: NCT01981421
• Lead Sponsor: Yonsei University

Brief Summary

Liver fibrosis has been considered as irreversible change. However, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. Liver biopsy is considered as golden standard for the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI, and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric MR imaging at the enrollment and one year later to evaluate changes in quantitative values in MR.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-11
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Last Update Submitted: 2013-11-04
• Study First Posted: 2013-11-11
• Last Update Posted: 2013-11-11
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who had chronic hepatitis
• Patients who underwent liver biopsy within 6 months
• Patients older than 18 years old

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Exclusion Criteria

• patient who had pregnancy
• patient 18 or below 18 years old

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment	1 year after enrollment	Elasticity, conventional ADC value, IVIM ADC value, T2\* value, T1 rho value will be compared before and after anti-viral treatment

Trial Locations

Locations (1)

Department of Radiology, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of