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

NCT04847726 | Completed

• 1 other identifier: SNUH-1807-166
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; Contrast-enhanced ultrasound; Perfluorobutane; Sulfur hexafluoride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic performance of perfulorobutane enhanced USG using different definition of washout

  up to 3 months

Other Outcomes (1)

• Role of perfluorobutane enhanced USG in EASL diagnostic algorithm of HCC

  up to 3 months

Study Arms (1)

CEUS with perfluorobutane and sulfur hexafluoride

EXPERIMENTAL

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

Diagnostic Test: contrast enhanced ultrasound; Diagnostic Test: Dynamic CT; Diagnostic Test: Liver MRI

Interventions

contrast enhanced ultrasound DIAGNOSTIC_TEST

contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride

CEUS with perfluorobutane and sulfur hexafluoride

Dynamic CT DIAGNOSTIC_TEST

Participants underwent dynamic CT for hepatic lesion

CEUS with perfluorobutane and sulfur hexafluoride

Liver MRI DIAGNOSTIC_TEST

Participants underwent liver MRI for hepatic lesion

CEUS with perfluorobutane and sulfur hexafluoride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• high-risk for HCC (liver cirrhosis, chronic hepatitis B)
• treatment-naive hepatic nodule (\>= 1cm) on preceding CT, MR or ultrasound

You may not qualify if:

• severe cardiopulmonary dysfunction
• pregnancy
• refusal to enroll study

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03038, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36196767 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeong Min Lee, Dr.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: June 9, 2020
• Primary Completion: July 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

KR (1)