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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
contrast enhanced ultrasound
Dynamic CT
Liver MRI
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring HCC, Contrast-enhanced ultrasound, Perfluorobutane, Sulfur hexafluoride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CEUS with perfluorobutane and sulfur hexafluoride

Arm Description

Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2021
Last Updated
December 2, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04847726
Brief Title
Contrast-enhanced Ultrasound With Perfluorobutane and Sulfur Hexafluoride for Hepatocellular Carcinoma
Official Title
Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC, Contrast-enhanced ultrasound, Perfluorobutane, Sulfur hexafluoride

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CEUS with perfluorobutane and sulfur hexafluoride
Arm Type
Experimental
Arm Description
Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
Intervention Type
Diagnostic Test
Intervention Name(s)
contrast enhanced ultrasound
Intervention Description
contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic CT
Intervention Description
Participants underwent dynamic CT for hepatic lesion
Intervention Type
Diagnostic Test
Intervention Name(s)
Liver MRI
Intervention Description
Participants underwent liver MRI for hepatic lesion
Primary Outcome Measure Information:
Title
Diagnostic accuracy for HCC: non-inferiority test
Description
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).
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Diagnostic performance of perfulorobutane enhanced USG using different definition of washout
Description
Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US
Time Frame
up to 3 months
Other Pre-specified Outcome Measures:
Title
Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC
Description
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
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, Dr.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03038
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36196767
Citation
Kang HJ, Lee JM, Yoon JH, Yoo J, Choi Y, Joo I, Han JK. Sonazoid versus SonoVue(R) for Diagnosing Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound in At-Risk Individuals: A Prospective, Single-Center, Intraindividual, Noninferiority Study. Korean J Radiol. 2022 Nov;23(11):1067-1077. doi: 10.3348/kjr.2022.0388. Epub 2022 Sep 30.
Results Reference
derived

Learn more about this trial

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

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