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Trial record 26 of 44 for:    Gadoxetate

Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

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ClinicalTrials.gov Identifier: NCT03742453
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Bracco Corporate
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE October 16, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Diagnostic performance of CEUS for diagnosing HCC [ Time Frame: 3 months after CEUS ]
accuracy, sensitivity, specificity of CEUS for HCC diagnosis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03742453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018 [ Time Frame: 3 months after MRI ]
    accuracy, sensitivity, specificity of MRI using LI-RADS v2018 for HCC diagnosis
  • Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018 [ Time Frame: 3 months after MRI ]
    accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis
Official Title  ICMJE Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis
Brief Summary This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Diagnostic Test: contrast-enhanced ultrasound
    CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
    Other Name: CEUS
  • Diagnostic Test: EOB-MRI
    EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
    Other Names:
    • gadoxetic acid MRI
    • Gd-EOB-MRI
Study Arms  ICMJE Experimental: Hepatic nodule group
This group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI)
Interventions:
  • Diagnostic Test: contrast-enhanced ultrasound
  • Diagnostic Test: EOB-MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
107
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • High risk group of developing HCC
  • hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
  • newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
  • scheduled for gadoxetic acid-enhanced liver MRI
  • signed informed consent

Exclusion Criteria:

  • hypersensitivity for ultrasound contrast media
  • pregnancy
  • history of recent treatment for HCC in a year
  • standard of reference is not available
  • severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hyun Hee Lee, RN 82-2-2072-4177 redlion55@naver.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742453
Other Study ID Numbers  ICMJE SNUH-2018-2268
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeong Min Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Bracco Corporate
Investigators  ICMJE
Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP