Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver (PriMPa)

January 26, 2014 updated by: Jae Ho Byun

Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver

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

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Liver cirrhosis is a progressive, diffuse disease of the liver characterized by hepatocyte necrosis, fibrosis, distortion of the normal hepatic architecture and a spectrum of nodular lesions that includes regenerative nodules (RN), dysplastic nodules (DN) and hepatocellular carcinomas (HCC). Since HCC is the leading cause of death among the patients with liver cirrhosis, Early and accurate diagnosis of HCC and its precursors by using optimal imaging technique is critical for its treatment and management.

Recently state-of-the-art magnetic resonance (MR) imaging with gadoxetic acid, which works both an extracellular and hepatocyte-specific contrast agent, has been increasing used to evaluate the patients with liver cirrhosis. Several studies correlated gadoxetic acid-enhanced MR of HCC and hepatocellular nodules with the pathology from biopsy or surgical resection specimens. However, all of those studies are limited by its lack of complete correlation between pathologic and imaging findings and the resulting bias being toward the positive studies. Ideally, the use of whole explant pathologic correlation would be helpful for exact characterization of HCC and its precursors on gadoxetic acid-enhanced MR.

The question of our study is how accurate gadoxetic acid-enhanced MR is in the evaluation of the patients with cirrhotic liver to detect HCC and dysplastic nodules and, by using thin-section whole-explant correlation following liver transplantation as the reference standard.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Within the first week after liver explantation
Within the first week after liver explantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference
Time Frame: Within the first week after liver explantation
Within the first week after liver explantation
Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules
Time Frame: Within one week after liver transplantation
To assess the diagnostic sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules in the cirrhotic liver, using thin-section whole-explant as standard of reference
Within one week after liver transplantation
To characterize borderline hepatocelluar nodules
Time Frame: Within one week after liver transplantation
To characterize borderline hepatocelluar nodules (i.e.,1-3cm sized nodules without arterial hypervascularity) in the cirrhotic liver detected on hepatobiliary phase of gadoxetic acid-enhanced MR
Within one week after liver transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jae Ho Byun

Collaborators

Bayer

Investigators

  • Principal Investigator: Jae Ho Byun, MD, PhD, University of Ulsan College of Medicine, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

December 26, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-2011-0797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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