Role of CEUS as a Secondary Diagnostic Modality

Seoul National University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Diagnostic Test: contrast enhanced ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04494022

2004-035-1116

Details and patient eligibility

About

To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

Full description

The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
• at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
• signed informed consent

Exclusion criteria

• congestive hepatopathies
• severe cardiovascular dysfunction
• no recent cross-sectional images within 4 weeks
• suboptimal cross-sectional images quality

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Cross-sectional image only

No Intervention group

Description:

Image set which consists of a Cross-sectional image only.

Cross-sectional image with CEUS

Active Comparator group

Description:

The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.

Treatment:

Diagnostic Test: contrast enhanced ultrasound