NCT01501240

Brief Summary

A prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as standard of reference

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

December 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

December 26, 2011

Last Update Submit

January 26, 2014

Conditions

Liver CirrhosisCarcinoma, Hepatocellular

Keywords

Magnetic resonance imagegadoxetic acidhepatocellular carcinomaliver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic sensitivity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as the standard of reference

    Within the first week after liver explantation

Secondary Outcomes (3)

  • Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference

    Within the first week after liver explantation

  • Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules

    Within one week after liver transplantation

  • To characterize borderline hepatocelluar nodules

    Within one week after liver transplantation

Study Arms (1)

liver cirrhosis, liver transplantation

Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month will be eligible population in the study

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month

You may qualify if:

  • Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data
  • Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data

You may not qualify if:

  • Patients under 20 years of age
  • Patients who have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced MR
  • Patients who underwent transarterial chemotherapy or radiofrequency ablation
  • Women who are pregnant, lactating or who are of childbearing potential
  • Patients with any physical or mental status than interferes with the signing of informed consent
  • Patients with a contraindication for MR
  • Patients with impaired renal function (e.g. acute renal failure or eGFR \< 30 ml/min/1.73m2) or patients on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (3)

  • Kudo M. Will Gd-EOB-MRI change the diagnostic algorithm in hepatocellular carcinoma? Oncology. 2010 Jul;78 Suppl 1:87-93. doi: 10.1159/000315235. Epub 2010 Jul 8.

    PMID: 20616589BACKGROUND

  • Zech CJ, Reiser MF, Herrmann KA. Imaging of hepatocellular carcinoma by computed tomography and magnetic resonance imaging: state of the art. Dig Dis. 2009;27(2):114-24. doi: 10.1159/000218343. Epub 2009 Jun 22.

    PMID: 19546549BACKGROUND

  • Tanimoto A, Lee JM, Murakami T, Huppertz A, Kudo M, Grazioli L. Consensus report of the 2nd International Forum for Liver MRI. Eur Radiol. 2009 Oct;19 Suppl 5:S975-89. doi: 10.1007/s00330-009-1624-y.

    PMID: 19851766BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Jae Ho Byun, MD, PhD

    University of Ulsan College of Medicine, Asan Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 26, 2011

First Posted

December 29, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

August 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

KR(2)