NCT03085342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

March 14, 2017

Last Update Submit

October 18, 2020

Conditions

CirrhosisHepatitis

Keywords

liverfibrosisMRI

Outcome Measures

Primary Outcomes (1)

  • hepatic fibrosis stage

    F0-1 vs. F2-4 using multiparametric MRI

    1 month after MRI

Secondary Outcomes (2)

  • presence of varix

    1 month after MRI

  • comparison of portal flow measurement

    1 month after MRI

Study Arms (1)

Liver MRI

EXPERIMENTAL

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

Diagnostic Test: Liver MRI

Interventions

Liver MRIDIAGNOSTIC_TEST

Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.

Liver MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

FibrosisHepatitis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

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

March 14, 2017

First Posted

March 21, 2017

Study Start

April 4, 2017

Primary Completion

September 25, 2019

Study Completion

December 1, 2021

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)