Skip to main content
OpenTrials
Completed

NCT Number: NCT04847726

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03038, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

contrast enhanced ultrasound

Diagnostic Test

contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride

Dynamic CT

Diagnostic Test

Participants underwent dynamic CT for hepatic lesion

Liver MRI

Diagnostic Test

Participants underwent liver MRI for hepatic lesion

Primary outcomes

  1. 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).

Secondary outcomes

  1. Diagnostic performance of perfulorobutane enhanced USG using different definition of washout

    Time frame: up to 3 months

    Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US

Other outcomes

  1. Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.