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

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188901
• Other study ID #: 4-2014-0337
• Status: Completed
• Phase: N/A
• First received: July 3, 2014
• Last updated: April 24, 2018
• Start date: October 15, 2014
• Est. completion date: August 3, 2016

Study information

• Verified date: April 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: August 3, 2016
• Est. primary completion date: August 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

Other:
• Sonazoid-enhanced ultrasonography
Sonazoid (perflubutane) [GE healthcare]

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	GE Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of early stage HCC	Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100	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
Primary	False referral rate of HCC	False referral rate of HCC =	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