Status:
COMPLETED
Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
GE Healthcare
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
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 ultrasono...
Eligibility Criteria
Inclusion
- Patient 20 years old or older,
- Patient at high risk of HCC and is supposed to take ultrasonography,
- Patient who has no suspicious HCC on previous examinations or patient who undergoes the first surveillance,
- 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,
- Patient without contraindication for sonazoid,
- Patient willing to sign the informed consent
Exclusion
- Patient on pregnancy or breast feeding,
- Patient with allergy to egg,
- Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension,
- Patient with history of HCC,
- Patient with history of malignancy other than HCC -
Key Trial Info
Start Date :
October 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2016
Estimated Enrollment :
523 Patients enrolled
Trial Details
Trial ID
NCT02188901
Start Date
October 15 2014
End Date
August 3 2016
Last Update
April 26 2018
Active Locations (1)
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1
Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea, 120-752