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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

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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Diagnostic Test: contrast-enhanced ultrasound Diagnostic Test: EOB-MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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)
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




Primary Outcome Measures :
  1. Diagnostic performance of CEUS for diagnosing HCC [ Time Frame: 3 months after CEUS ]
    accuracy, sensitivity, specificity of CEUS for HCC diagnosis


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742453


Contacts
Contact: Hyun Hee Lee, RN 82-2-2072-4177 redlion55@naver.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun Hee Lee, RN    82-2-2072-4177    redlion55@naver.com   
Contact: Jeong Hee Yoon, MD    82-2-2072-2584    jhjhry@gmail.com   
Principal Investigator: Jeong Min Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Bracco Corporate
Investigators
Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03742453     History of Changes
Other Study ID Numbers: SNUH-2018-2268
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeong Min Lee, Seoul National University Hospital:
CEUS
gadoxetic acid
MRI

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases