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Clinical Trials/NCT02480972
NCT02480972CompletedNot Applicable

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)

Seoul National University Hospital1 site in 1 country69 target enrollmentStarted: June 23, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
69
Locations
1
Primary Endpoint
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis

Study Overview

Brief Summary

The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.

Detailed Description

In patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included.

Referred patients undergo multiparametric MRI including perfusion, diffusion, elastography and fat quantification before surgery or biopsy.

The pathophysiologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients who are scheduled to undergo liver resection for focal liver lesion
  • patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease
  • liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection
  • AND patients/living donor candidates who sign informed consent

Exclusion Criteria

  • Patients who have at least one of followings are excluded.
  • Patients who are contraindication for MRI contrast enhanced MRI.
  • Premenopausal female patients who are pregnant.
  • Patients who are physically compromised to acquire liver MRI

Outcomes

Primary Outcomes

difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis

Time Frame: in three years

Secondary Outcomes

  • difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis(in three years)
  • difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis(in three years)
  • monitoring of transient dyspnea after contrast media injection(in three years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Study Sites (1)

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