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CompletedNCT02480972Updated Dec 17, 2021

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

An interventional study of magnetic resonance imaging in Fibrosis and Cirrhosis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fibrosis
  • Cirrhosis

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Keywords

  • fibrosis
  • cirrhosis
  • MRI
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's enrollment of 69 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Other
    Magnetic resonance imaging

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

    Procedure: magnetic resonance imaging

Interventions

  • Proceduremagnetic 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)

    Also known as: MRI

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What researchers measure

Primary outcomes

  1. difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis

    Time frame: in three years

Secondary outcomes

  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

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02480972
Lead sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
Responsible party
Jeong Min Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 25, 2015
Start date
Jun 23, 2015
Primary completion
Sep 20, 2016
Completion
Aug 28, 2020
Last update
Dec 17, 2021

Study contacts

Jeong Min Lee, MD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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