Back to resultsHepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging
Primary Purpose
Fibrosis, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Fibrosis focused on measuring fibrosis, cirrhosis, MRI
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Magnetic resonance imaging
Arm Description
multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography
Outcomes
Primary Outcome Measures
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Secondary Outcome Measures
difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis
difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis
monitoring of transient dyspnea after contrast media injection
Full Information
NCT ID
NCT02480972
First Posted
June 18, 2015
Last Updated
December 16, 2021
Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02480972
Brief Title
Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging
Official Title
Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2015 (Actual)
Primary Completion Date
September 20, 2016 (Actual)
Study Completion Date
August 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Cirrhosis
Keywords
fibrosis, cirrhosis, 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
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic resonance imaging
Arm Type
Other
Arm Description
multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
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)
Primary Outcome Measure Information:
Title
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Time Frame
in three years
Secondary Outcome Measure Information:
Title
difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Time Frame
in three years
Title
difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis
Time Frame
in three years
Title
monitoring of transient dyspnea after contrast media injection
Time Frame
in three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Learn more about this trial
Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging
We'll reach out to this number within 24 hrs