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Role of CEUS as a Secondary Diagnostic Modality

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
contrast enhanced ultrasound
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Cross-sectional image only

Cross-sectional image with CEUS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation
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.
Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.

Secondary Outcome Measures

Comparing image characters between two types of ultrasound contrast media
Comparing image characters between two types of ultrasound contrast media

Full Information

First Posted
June 5, 2020
Last Updated
July 27, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04494022
Brief Title
Role of CEUS as a Secondary Diagnostic Modality
Official Title
Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cross-sectional image only
Arm Type
No Intervention
Arm Description
Image set which consists of a Cross-sectional image only.
Arm Title
Cross-sectional image with CEUS
Arm Type
Active Comparator
Arm Description
The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.
Intervention Type
Diagnostic Test
Intervention Name(s)
contrast enhanced ultrasound
Intervention Description
Perflubutane enhanced ultrasound for evaluating hepatic tumor
Primary Outcome Measure Information:
Title
Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation
Description
Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.
Time Frame
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.
Title
Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.
Description
Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.
Time Frame
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 Information:
Title
Comparing image characters between two types of ultrasound contrast media
Description
Comparing image characters between two types of ultrasound contrast media
Time Frame
For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Jin Kang, M.D.
Phone
82220723107
Email
dr.kanghj@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Hee Lee, B.S.
Phone
82220723107
Email
redlion55@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, M.D.
Organizational Affiliation
Seoul National University
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
For two years after publication.
IPD Sharing Access Criteria
except you want to use illegal purpose

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Role of CEUS as a Secondary Diagnostic Modality

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