Contrast-enhanced Ultrasound With Perfluorobutane and Sulfur Hexafluoride for Hepatocellular Carcinoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04847726

Enrollment

110

Registered

2021-04-19

Start date

2020-06-09

Completion date

2021-10-30

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

HCC, Contrast-enhanced ultrasound, Perfluorobutane, Sulfur hexafluoride

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.

Interventions

DIAGNOSTIC_TESTcontrast enhanced ultrasound

contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride

DIAGNOSTIC_TESTDynamic CT

Participants underwent dynamic CT for hepatic lesion

DIAGNOSTIC_TESTLiver MRI

Participants underwent liver MRI for hepatic lesion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy for HCC: non-inferiority test	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).

Secondary

Measure	Time frame	Description
Diagnostic performance of perfulorobutane enhanced USG using different definition of washout	up to 3 months	Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US

Other

Measure	Time frame	Description
Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC	up to 3 months	The number of perfluorobutane enhanced USG diagnosed HCC that were missed by prior gadoxetic-acid MRI to simulate diagnostic algorithm for HCC and reveal the role of PFB-US as a second-line diagnostic modality

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026