Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2015
CompletedStudy Start
First participant enrolled
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2020
CompletedDecember 17, 2021
December 1, 2021
1.2 years
June 18, 2015
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis
in three years
Secondary Outcomes (3)
difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis
in three years
difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis
in three years
monitoring of transient dyspnea after contrast media injection
in three years
Study Arms (1)
Magnetic resonance imaging
OTHERmultiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who are contraindication for MRI contrast enhanced MRI.
- Premenopausal female patients who are pregnant.
- Patients who are physically compromised to acquire liver MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 25, 2015
Study Start
June 23, 2015
Primary Completion
September 20, 2016
Study Completion
August 28, 2020
Last Updated
December 17, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share