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Clinical Trials/NCT01981421
NCT01981421UnknownNot Applicable

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

Yonsei University1 site in 1 country60 target enrollmentStarted: June 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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