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临床试验/NCT01501240
NCT01501240撤回不适用

Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver

Jae Ho Byun2 个研究点 分布在 1 个国家开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
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

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: Within the first week after liver explantation

次要结局

  • 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(Within one week after liver transplantation)
  • To characterize borderline hepatocelluar nodules(Within one week after liver transplantation)

研究者

发起方
Jae Ho Byun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jae Ho Byun

Associate Professor

Asan Medical Center

研究点 (2)

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