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

Liver Fibrosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01981421
• Other study ID #: 4-2011-0193
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2013
• Last updated: November 4, 2013
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: Yonsei University
• Contact: Mi-Suk Park, MD
• Phone: 82-2-2228-7400
• Email: radpms[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board (Severance Hospital)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Liver Fibrosis

Locations

Country	Name	City	State
Korea, Republic of	Department of Radiology, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment	Elasticity, conventional ADC value, IVIM ADC value, T2* value, T1 rho value will be compared before and after anti-viral treatment	1 year after enrollment	No