Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound

Seoul National University Hospital1 site in 1 country110 target enrollmentJune 9, 2020

ConditionsHepatocellular Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Seoul National University Hospital
Enrollment: 110
Locations: 1
Primary Endpoint: Diagnostic accuracy for HCC: non-inferiority test
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.

Detailed Description

The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.

Registry

clinicaltrials.gov

Start Date

June 9, 2020

End Date

October 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•high-risk for HCC (liver cirrhosis, chronic hepatitis B)
•treatment-naive hepatic nodule (\>= 1cm) on preceding CT, MR or ultrasound

Exclusion Criteria

•severe cardiopulmonary dysfunction
•pregnancy
•refusal to enroll study

Outcomes

Primary Outcomes

Diagnostic accuracy for HCC: non-inferiority test

Time Frame: up to 3 months

The per-lesion diagnostic accuracy for HCC of CEUS with perfluorobutane and sulfur hexafluoride using the same diagnostic criteria (arterial phase hyperenehancement with mild and late (≥ 60 sec) washout).