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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01501240
Other study ID # AMC-2011-0797
Secondary ID
Status Withdrawn
Phase N/A
First received December 26, 2011
Last updated January 26, 2014
Start date January 2012
Est. completion date August 2013

Study information

Verified date January 2014
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Jae Ho Byun Bayer

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules 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 No
Secondary To characterize borderline hepatocelluar nodules 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 No
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