Fusion Imaging Contrast-enhanced Ultrasound LI-RADS

NCT ID: NCT04955119

Last Updated: 2021-07-08

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2021-12-31

Brief Summary

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CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fusion imaging contrast-enhanced ultrasound LI-RADS

Fusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound.

Drug: SonoVue

Group Type EXPERIMENTAL

Fusion imaging contrast-enhanced ultrasound

Intervention Type DIAGNOSTIC_TEST

Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound.

Drug: SonoVue

Interventions

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Fusion imaging contrast-enhanced ultrasound

Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound.

Drug: SonoVue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.

Exclusion Criteria

Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiang Jing, MD

Role: CONTACT

02284112323 ext. +86

Yan Zhou, MD

Role: CONTACT

02284118101 ext. +86

Other Identifiers

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dr.jingxiang003

Identifier Type: -

Identifier Source: org_study_id

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