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

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sonazoid-enhanced ultrasonography

About this trial

This is an interventional screening trial for Hepatocellular Carcinoma (HCC) focused on measuring HCC, Sonazoid, Ultrasonography, Screening

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Severance Hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm

Arm Description

Outcomes

Primary Outcome Measures

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

False referral rate of HCC

False referral rate of HCC =

Secondary Outcome Measures

Full Information

NCT ID

NCT02188901

First Posted

July 3, 2014

Last Updated

April 24, 2018

Sponsor

Yonsei University

Collaborators

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02188901

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 15, 2014 (Actual)

Primary Completion Date

August 3, 2016 (Actual)

Study Completion Date

August 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

Collaborators

GE Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. 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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma (HCC)

Keywords

HCC, Sonazoid, Ultrasonography, Screening

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

523 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Sonazoid-enhanced ultrasonography

Other Intervention Name(s)

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

Intervention Description

Sonazoid (perflubutane) [GE healthcare]

Primary Outcome Measure Information:

Title

Detection rate of early stage HCC

Description

Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100

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

Title

False referral rate of HCC

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Facility Information:

Facility Name

Severance Hospital, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

31287387

Citation

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.

Results Reference

derived

PubMed Identifier

28420329

Citation

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.

Results Reference

derived

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

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