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

Not Applicable
Completed
Conditions
Hepatocellular Carcinoma
Registration Number
NCT04847726
Lead Sponsor
Seoul National University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
110
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Diagnostic accuracy for HCC: non-inferiority testup 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 Outcome Measures
NameTimeMethod
Diagnostic performance of perfulorobutane enhanced USG using different definition of washoutup to 3 months

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

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Jongno-gu, Korea, Republic of

Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of

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