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Trial record 32 of 44 for:    Gadoxetate

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

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ClinicalTrials.gov Identifier: NCT01501240
Recruitment Status : Withdrawn
First Posted : December 29, 2011
Last Update Posted : January 28, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jae Ho Byun, Asan Medical Center

Tracking Information
First Submitted Date December 26, 2011
First Posted Date December 29, 2011
Last Update Posted Date January 28, 2014
Study Start Date January 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2011)
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 ]
Original Primary Outcome Measures
 (submitted: December 26, 2011)
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: Withing the first week after liver explantation ]
Change History Complete list of historical versions of study NCT01501240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 10, 2012)
  • 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 ]
  • Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules [ Time Frame: Within one week after liver transplantation ]
    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 ]
    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
Original Secondary Outcome Measures
 (submitted: December 26, 2011)
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: Withing the first week after liver explantation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver
Official Title Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver
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 reference
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month
Condition
  • Liver Cirrhosis
  • Carcinoma, Hepatocellular
Intervention Not Provided
Study Groups/Cohorts 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 26, 2014)
0
Original Estimated Enrollment
 (submitted: December 26, 2011)
100
Estimated Study Completion Date August 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01501240
Other Study ID Numbers AMC-2011-0797
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jae Ho Byun, Asan Medical Center
Study Sponsor Jae Ho Byun
Collaborators Bayer
Investigators
Principal Investigator: Jae Ho Byun, MD, PhD University of Ulsan College of Medicine, Asan Medical Center
PRS Account Asan Medical Center
Verification Date January 2014