Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study
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ClinicalTrials.gov Identifier: NCT02188901 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : April 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma (HCC) | Other: Sonazoid-enhanced ultrasonography | Not Applicable |
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 |

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 |
- 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
- 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 =

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188901
Korea, Republic of | |
Severance Hospital, Yonsei University College of Medicine | |
Seoul, Korea, Republic of, 120-752 |
Responsible Party: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT02188901 |
Other Study ID Numbers: |
4-2014-0337 |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | April 26, 2018 |
Last Verified: | April 2018 |
HCC Sonazoid Ultrasonography Screening |
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 |