Fusion Imaging Contrast-enhanced Ultrasound LI-RADS

Hepatocellular Carcinoma Clinical Trial

Official title:

Fusion Imaging Contrast-enhanced Ultrasound LI-RADS in Patients With High-risk Hepatocellular Carcinoma With Focal Liver Lesions Invisible on Conventional Ultrasound: a Multi-center Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04955119
• Other study ID #: dr.jingxiang003
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Tianjin Third Central Hospital
• Contact: Xiang Jing, MD
• Phone: 02284112323
• Email: dr.jingxiang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Fusion imaging contrast-enhanced ultrasound
Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound. Drug: SonoVue

Locations

Country	Name	City	State
China	Tianjin Third Central Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Third Central Hospital	Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive predictive value	The positive predictive value = HCC in LR-5 /all lesions in LR-5	6 months
Secondary	The sensitivity and specificity of CEUS LR-5	The sensitivity and specificity are calculated.	6 months