Role of CEUS as a Secondary Diagnostic Modality

Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04494022

Enrollment

120

Registered

2020-07-31

Start date

2020-06-08

Completion date

2021-12-31

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTcontrast enhanced ultrasound

Perflubutane enhanced ultrasound for evaluating hepatic tumor

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Intervention model description

All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation	1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.	Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.
Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.	1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.	Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.

Secondary

Measure	Time frame	Description
Comparing image characters between two types of ultrasound contrast media	For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.	Comparing image characters between two types of ultrasound contrast media

Countries

South Korea

Contacts

Primary ContactHyo-Jin Kang, M.D.

dr.kanghj@gmail.com82220723107

Backup ContactHyun-Hee Lee, B.S.

redlion55@naver.com82220723107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026