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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

523 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-15

Study Completion Date

2016-08-03

Brief Summary

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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%).

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Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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single arm

Group Type OTHER

Sonazoid-enhanced ultrasonography

Intervention Type OTHER

Sonazoid (perflubutane) \[GE healthcare\]

Interventions

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Sonazoid-enhanced ultrasonography

Sonazoid (perflubutane) \[GE healthcare\]

Intervention Type OTHER

Other Intervention Names

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0.015ml/kg of suspension containing 16μl of perflubutane microbubble and 2ml of diluent, IV (in the vein) on day 1

Eligibility Criteria

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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 -

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No