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Completed

NCT Number: NCT02480972

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

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.

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Key information

Conditions

Fibrosis Cirrhosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Procedure

multiparametric MRI as follows:

  • diffusion weighted imaging using multiple b-values
  • Fat quantification sequence
  • perfusion MRI using ECCM agent
  • MR elastography

------------------------------------

  • routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion)

Other names: MRI

Primary outcomes

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

    Time frame: in three years

Secondary outcomes

  1. difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis

    Time frame: in three years

  2. difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis

    Time frame: in three years

  3. monitoring of transient dyspnea after contrast media injection

    Time frame: in three years

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)

Important dates

Study start
2015
Primary completion
2016
Study completion
2020
First posted
Jun 25, 2015
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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