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

NCT ID: NCT01981421

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Liver Fibrosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Liver fibrosis

patients who had chronic liver disease

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Radiology, Yonsei University Health System

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Mi-Suk Park, MD

Role: CONTACT

radpms@yuhs.ac

82-2-2228-7400

Facility Contacts

Mi-Suk Park, MD

Role: primary

radpms@yuhs.ac

82-2-2228-7400

Other Identifiers

4-2011-0193

Identifier Type: -

Identifier Source: org_study_id