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Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

NCT ID: NCT02480972

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-23

Study Completion Date

2020-08-28

Brief Summary

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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

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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.

Conditions

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Fibrosis Cirrhosis

Keywords

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fibrosis cirrhosis MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetic resonance imaging

multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography

Group Type OTHER

magnetic resonance imaging

Intervention Type PROCEDURE

multiparametric MRI as follows:

1. diffusion weighted imaging using multiple b-values
2. Fat quantification sequence
3. perfusion MRI using ECCM agent
4. MR elastography

\------------------------------------
5. routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion)

Interventions

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magnetic resonance imaging

multiparametric MRI as follows:

1. diffusion weighted imaging using multiple b-values
2. Fat quantification sequence
3. perfusion MRI using ECCM agent
4. MR elastography

\------------------------------------
5. routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion)

Intervention Type PROCEDURE

Other Intervention Names

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MRI

Eligibility Criteria

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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 are contraindication for MRI contrast enhanced MRI.
* Premenopausal female patients who are pregnant.
* Patients who are physically compromised to acquire liver MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-082-618

Identifier Type: -

Identifier Source: org_study_id