Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver (PriMPa)
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Purpose
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
| Condition |
|---|
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Liver Cirrhosis Carcinoma, Hepatocellular |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver |
- 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 [ Time Frame: Within the first week after liver explantation ] [ Designated as safety issue: No ]
- Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference [ Time Frame: Within the first week after liver explantation ] [ Designated as safety issue: No ]
- Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules [ Time Frame: Within one week after liver transplantation ] [ Designated as safety issue: No ]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
- To characterize borderline hepatocelluar nodules [ Time Frame: Within one week after liver transplantation ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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liver cirrhosis, liver transplantation
Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month will be eligible population in the study
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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| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month
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
Contacts and Locations| Contact: Jae Ho Byun, MD,PhD | 82-2-3010-4387 | jhbyun@amc.seoul.kr |
| Contact: So Yeon Kim, MD | 82-2-3010-5980 | sykimsnubh@gmail.com |
| Korea, Republic of | |
| Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Principal Investigator: Jae Ho Byun, MD, PhD | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Jae Ho Byun, MD, PhD 82-2-3010-4400 jhbyun@amc.seoul.kr | |
| Principal Investigator: | Jae Ho Byun, MD, PhD | University of Ulsan College of Medicine, Asan Medical Center |
More Information
Publications:
| Responsible Party: | Jae Ho Byun, Associate Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01501240 History of Changes |
| Other Study ID Numbers: | AMC-2011-0797 |
| Study First Received: | December 26, 2011 |
| Last Updated: | January 10, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Asan Medical Center:
|
Magnetic resonance image gadoxetic acid hepatocellular carcinoma liver cirrhosis |
Additional relevant MeSH terms:
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Carcinoma Liver Cirrhosis Fibrosis Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Liver Diseases Digestive System Diseases Pathologic Processes Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013