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Evaluation of Hepatic Fibrosis on Multiparametric MRI

Primary Purpose

Cirrhosis, Hepatitis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Liver MRI
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring liver, fibrosis, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
  • Or transplant recipient for viral hepatitis and on anti-viral agent medication
  • AND scheduled for liver resection, biopsy or transient elastography
  • AND signed informed consent

Exclusion Criteria:

  • younger than 18 years
  • any contra-indication for contrast-enhanced MRI
  • pregnant or nursing women
  • biliary obstruction
  • unable or unwilling to give informed consent

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver MRI

Arm Description

Liver MRI including noncontrast (precontrast) flow measurement, DCE, DWI using multiple b-values, MRE and MR fat quantification.

Outcomes

Primary Outcome Measures

hepatic fibrosis stage
F0-1 vs. F2-4 using multiparametric MRI

Secondary Outcome Measures

presence of varix
presence of esophageal or gastric varices using multiparametric MRI
comparison of portal flow measurement
comparison of portal flow measurement using DCE and precontrast flow measurement

Full Information

First Posted
March 14, 2017
Last Updated
October 18, 2020
Sponsor
Seoul National University Hospital
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03085342
Brief Title
Evaluation of Hepatic Fibrosis on Multiparametric MRI
Official Title
Evaluation of Hepatic Fibrosis on Multiparametric MRI Including Portal Flow Measurement Using Dual-input Software: Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Hepatitis
Keywords
liver, fibrosis, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liver MRI
Arm Type
Experimental
Arm Description
Liver MRI including noncontrast (precontrast) flow measurement, DCE, DWI using multiple b-values, MRE and MR fat quantification.
Intervention Type
Diagnostic Test
Intervention Name(s)
Liver MRI
Intervention Description
Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.
Primary Outcome Measure Information:
Title
hepatic fibrosis stage
Description
F0-1 vs. F2-4 using multiparametric MRI
Time Frame
1 month after MRI
Secondary Outcome Measure Information:
Title
presence of varix
Description
presence of esophageal or gastric varices using multiparametric MRI
Time Frame
1 month after MRI
Title
comparison of portal flow measurement
Description
comparison of portal flow measurement using DCE and precontrast flow measurement
Time Frame
1 month after MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...) Or transplant recipient for viral hepatitis and on anti-viral agent medication AND scheduled for liver resection, biopsy or transient elastography AND signed informed consent Exclusion Criteria: younger than 18 years any contra-indication for contrast-enhanced MRI pregnant or nursing women biliary obstruction unable or unwilling to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Hepatic Fibrosis on Multiparametric MRI

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