NCT02188901

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%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
523

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2016

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

July 3, 2014

Last Update Submit

April 24, 2018

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

HCCSonazoidUltrasonographyScreening

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

single arm

OTHER
Other: Sonazoid-enhanced ultrasonography

Interventions

Sonazoid-enhanced ultrasonographyOTHER

Sonazoid (perflubutane) \[GE healthcare\]

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 31287387DERIVED

  • 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.

    PMID: 28420329DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 14, 2014

Study Start

October 15, 2014

Primary Completion

August 3, 2016

Study Completion

August 3, 2016

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

KR(1)