Clinical trial NCT01501240: Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver
Official title: Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Liver Cirrhosis
Carcinoma, Hepatocellular
Keywords: Magnetic resonance image
gadoxetic acid
hepatocellular carcinoma
liver cirrhosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month

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

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 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

Primary outcomes:
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
timeFrame: Within the first week after liver explantation
Secondary outcomes:
measure: Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference
timeFrame: Within the first week after liver explantation
measure: Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules
timeFrame: Within one week after liver transplantation
measure: To characterize borderline hepatocelluar nodules
timeFrame: Within one week after liver transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: University of Ulsan College of Medicine, Asan Medical Center
name: Jae Ho Byun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.