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Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT02480972
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Fibrosis Cirrhosis Procedure: magnetic resonance imaging Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)
Study Start Date : June 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Magnetic resonance imaging
multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography
Procedure: 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)
Other Name: MRI




Primary Outcome Measures :
  1. difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis [ Time Frame: in three years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480972


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
National Research Foundation of Korea
Investigators
Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02480972     History of Changes
Other Study ID Numbers: SNUH-082-618
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeong Min Lee, Seoul National University Hospital:
fibrosis
cirrhosis
MRI

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes