Liver Cirrhosis Clinical Trial
— PriMPaOfficial title:
Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver
Verified date | January 2014 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Observational |
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
Status | Withdrawn |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 |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Jae Ho Byun | Bayer |
Korea, Republic of,
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
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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