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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847726
• Other study ID #: SNUH-1807-166
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• contrast enhanced ultrasound
contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride
• Dynamic CT
Participants underwent dynamic CT for hepatic lesion
• Liver MRI
Participants underwent liver MRI for hepatic lesion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC	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	up to 3 months
Primary	Diagnostic accuracy for HCC: non-inferiority test	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).	up to 3 months
Secondary	Diagnostic performance of perfulorobutane enhanced USG using different definition of washout	Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US	up to 3 months