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

Sponsors

Lead Sponsor: Seoul National University Hospital

Source Seoul National University Hospital
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.

Overall Status Recruiting
Start Date June 8, 2020
Completion Date December 31, 2021
Primary Completion Date June 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 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.
Secondary Outcome
Measure Time Frame
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.
Enrollment 120
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: contrast enhanced ultrasound

Description: Perflubutane enhanced ultrasound for evaluating hepatic tumor

Arm Group Label: Cross-sectional image with CEUS

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jeong Min Lee, M.D. Study Director Seoul National University
Overall Contact

Last Name: Hyo-Jin Kang, M.D.

Phone: 82220723107

Email: [email protected]

Location
Facility: Status: Investigator: Seoul National University Hospital Jeong Min Lee, MD, PhD Principal Investigator
Location Countries

Korea, Republic of

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Jeong Min Lee

Investigator Title: Pf.

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cross-sectional image only

Type: No Intervention

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

Label: Cross-sectional image with CEUS

Type: Active Comparator

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

Patient Data Yes
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

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.

Primary Purpose: Diagnostic

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov