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Role of CEUS as a Secondary Diagnostic Modality

NCT ID: NCT04494022

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cross-sectional image only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Cross-sectional image with CEUS

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

Group Type ACTIVE_COMPARATOR

contrast enhanced ultrasound

Intervention Type DIAGNOSTIC_TEST

Perflubutane enhanced ultrasound for evaluating hepatic tumor

Interventions

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contrast enhanced ultrasound

Perflubutane enhanced ultrasound for evaluating hepatic tumor

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Pf.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, M.D.

Role: STUDY_DIRECTOR

Seoul National University

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo-Jin Kang, M.D.

Role: CONTACT

Phone: 82220723107

Email: [email protected]

Hyun-Hee Lee, B.S.

Role: CONTACT

Phone: 82220723107

Email: [email protected]

Other Identifiers

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2004-035-1116

Identifier Type: -

Identifier Source: org_study_id