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

NCT01981421 | Unknown DMC

• 1 other identifier: 4-2011-0193
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Liver fibrosis; Elastography; MR Elastography; Quantitative imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Liver fibrosis

patients who had chronic liver disease

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have chronic liver disease and who are planned to receive anti-viral treatment.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Radiology, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mi-Suk Park, MD

CONTACT

82-2-2228-7400; radpms@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

KR (1)