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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Liver Cirrhosis, Carcinoma, Hepatocellular

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| liver cirrhosis, liver transplantation<br>Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month will be eligible population in the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance image, gadoxetic acid, hepatocellular carcinoma, liver cirrhosis