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

NCT ID: NCT04847726

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2021-10-30

Brief Summary

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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

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

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CEUS with perfluorobutane and sulfur hexafluoride

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

Group Type EXPERIMENTAL

contrast enhanced ultrasound

Intervention Type DIAGNOSTIC_TEST

contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride

Dynamic CT

Intervention Type DIAGNOSTIC_TEST

Participants underwent dynamic CT for hepatic lesion

Liver MRI

Intervention Type DIAGNOSTIC_TEST

Participants underwent liver MRI for hepatic lesion

Interventions

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contrast enhanced ultrasound

contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride

Intervention Type DIAGNOSTIC_TEST

Dynamic CT

Participants underwent dynamic CT for hepatic lesion

Intervention Type DIAGNOSTIC_TEST

Liver MRI

Participants underwent liver MRI for hepatic lesion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, Dr.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36196767 (View on PubMed)

Other Identifiers

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SNUH-1807-166

Identifier Type: -

Identifier Source: org_study_id

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