Status:
WITHDRAWN
Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver
Lead Sponsor:
Jae Ho Byun
Collaborating Sponsors:
Bayer
Conditions:
Liver Cirrhosis
Carcinoma, Hepatocellular
Eligibility:
All Genders
20-80 years
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 refer...
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 incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01501240
Start Date
January 1 2012
End Date
August 1 2013
Last Update
January 28 2014
Active Locations (2)
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1
Asan Medical Center
Seoul, South Korea, 138-736
2
Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, South Korea, 138-736