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


N/A
20 Years
80 Years
Open (Enrolling)
Both
Liver Cirrhosis, Carcinoma, Hepatocellular

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Within the first week after liver explantation

Safety Issue:

No

Principal Investigator

Jae Ho Byun, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Ulsan College of Medicine, Asan Medical Center

Authority:

Korea: Institutional Review Board

Study ID:

AMC-2011-0797

NCT ID:

NCT01501240

Start Date:

January 2012

Completion Date:

August 2013

Related Keywords:

  • Liver Cirrhosis
  • Carcinoma, Hepatocellular
  • Magnetic resonance image
  • gadoxetic acid
  • hepatocellular carcinoma
  • liver cirrhosis
  • Carcinoma
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular

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