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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: contrast enhanced ultrasound; Diagnostic Test: Dynamic CT; Diagnostic Test: Liver MRI

• Registration Number: NCT04847726
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2020-06-09
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-19
• Primary Completion: 2021-07-30
• Study Completion: 2021-10-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CEUS with perfluorobutane and sulfur hexafluoride	Dynamic CT	Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
CEUS with perfluorobutane and sulfur hexafluoride	Liver MRI	Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
CEUS with perfluorobutane and sulfur hexafluoride	contrast enhanced ultrasound	Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of