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Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02188901
First received: July 3, 2014
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So our aim is to compare the detection rate of early stage HCC and false referral rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%) than that of B-mode US (3%).

Condition Intervention
Hepatocellular Carcinoma (HCC) Other: Sonazoid-enhanced ultrasonography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Detection rate of early stage HCC [ Time Frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US ]
    Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100


Secondary Outcome Measures:
  • False referral rate of HCC [ Time Frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US ]
    False referral rate of HCC = (Number of HCCs falsely called by a given modality) / (Total number of patients enrolled) x 100


Enrollment: 523
Study Start Date: June 2014
Study Completion Date: August 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm Other: Sonazoid-enhanced ultrasonography
Sonazoid (perflubutane) [GE healthcare]
Other Name: 0.015ml/kg of suspension containing 16μl of perflubutane microbubble and 2ml of diluent, IV (in the vein) on day 1

  Eligibility

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

Inclusion Criteria:

  1. Patient 20 years old or older,
  2. Patient at high risk of HCC and is supposed to take ultrasonography,
  3. Patient who has no suspicious HCC on previous examinations or patient who undergoes the first surveillance,
  4. Patient who has liver cirrhosis proven by one of the following methods-liver biopsy (METAVIR score 4), identification of esophageal or gastric varix by endoscopically or radiologically, surface nodularity on ultrasonography, CT or MRI, platelet count less than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than 1.3 INR,
  5. Patient without contraindication for sonazoid,
  6. Patient willing to sign the informed consent

Exclusion Criteria:

  1. Patient on pregnancy or breast feeding,
  2. Patient with allergy to egg,
  3. Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension,
  4. Patient with history of HCC,
  5. Patient with history of malignancy other than HCC -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02188901

Locations
Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
GE Healthcare
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02188901     History of Changes
Other Study ID Numbers: 4-2014-0337
Study First Received: July 3, 2014
Last Updated: October 17, 2016

Keywords provided by Yonsei University:
HCC
Sonazoid
Ultrasonography
Screening

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

ClinicalTrials.gov processed this record on June 28, 2017