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

December 2, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03038
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CEUS with perfluorobutane and sulfur hexafluoride
Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
Diagnostic test: contrast enhanced ultrasound
contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride
Diagnostic test: Dynamic CT
Participants underwent dynamic CT for hepatic lesion
Diagnostic test: Liver MRI
Participants underwent liver MRI for hepatic lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jeong Min Lee, Dr., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2020

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-1807-166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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