Fusion Imaging Contrast-enhanced Ultrasound LI-RADS

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: Fusion imaging contrast-enhanced ultrasound

• Registration Number: NCT04955119
• Lead Sponsor: Tianjin Third Central Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-03
• Last Update Submitted: 2021-07-03
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Study Start: 2021-07-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fusion imaging contrast-enhanced ultrasound LI-RADS	Fusion imaging contrast-enhanced ultrasound	Fusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound. Drug: SonoVue

Primary Outcome Measures

Name	Time	Method
Positive predictive value	6 months	The positive predictive value = HCC in LR-5 /all lesions in LR-5

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of CEUS LR-5	6 months	The sensitivity and specificity are calculated.

Trial Locations

Locations (1)

Tianjin Third Central Hospital; 🇨🇳 Tianjin, Tianjin, China