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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jae Ho Byun, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01501240
First received: December 26, 2011
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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


Condition
Liver Cirrhosis
Carcinoma, Hepatocellular

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules [ Time Frame: Within one week after liver transplantation ] [ Designated as safety issue: No ]
    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

  • To characterize borderline hepatocelluar nodules [ Time Frame: Within one week after liver transplantation ] [ Designated as safety issue: No ]
    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


Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501240

Locations
Korea, Republic of
Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Jae Ho Byun
Bayer
Investigators
Principal Investigator: Jae Ho Byun, MD, PhD University of Ulsan College of Medicine, Asan Medical Center
  More Information

Publications:
Responsible Party: Jae Ho Byun, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01501240     History of Changes
Other Study ID Numbers: AMC-2011-0797
Study First Received: December 26, 2011
Last Updated: January 26, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Magnetic resonance image
gadoxetic acid
hepatocellular carcinoma
liver cirrhosis

Additional relevant MeSH terms:
Carcinoma
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 17, 2014