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

• ClinicalTrials.gov Identifier: NCT02188901
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: April 26, 2018
• Sponsor: Yonsei University
• Collaborator: GE Healthcare
• Information provided by (Responsible Party): Yonsei University

Study Description

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 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 or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma (HCC)	Other: Sonazoid-enhanced ultrasonography	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 523 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: October 15, 2014
• Actual Primary Completion Date: August 3, 2016
• Actual Study Completion Date: August 3, 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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 =

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Park JH, Park MS, Lee SJ, Jeong WK, Lee JY, Park MJ, Lee SS, Han K, Nam CM, Park SH, Lee KH. Contrast-enhanced US with Perfluorobutane for Hepatocellular Carcinoma Surveillance: A Multicenter Diagnostic Trial (SCAN). Radiology. 2019 Sep;292(3):638-646. doi: 10.1148/radiol.2019190183. Epub 2019 Jul 9.

Park JH, Park MS, Lee SJ, Jeong WK, Lee JY, Park MJ, Han K, Nam CM, Park SH, Lee KH. Contrast-enhanced US with Perfluorobutane(Sonazoid) used as a surveillance test for Hepatocellular Carcinoma (HCC) in Cirrhosis (SCAN): an exploratory cross-sectional study for a diagnostic trial. BMC Cancer. 2017 Apr 18;17(1):279. doi: 10.1186/s12885-017-3267-8.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02188901
• Other Study ID Numbers: 4-2014-0337
• First Posted: July 14, 2014
• Last Update Posted: April 26, 2018
• Last Verified: April 2018

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