Fusion Imaging Contrast-enhanced Ultrasound LI-RADS

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04955119

Enrollment

132

Registered

2021-07-08

Start date

2021-07-30

Completion date

2021-12-31

Last updated

2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

DIAGNOSTIC_TESTFusion imaging contrast-enhanced ultrasound

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Positive predictive value	6 months	The positive predictive value = HCC in LR-5 /all lesions in LR-5

Secondary

Measure	Time frame	Description
The sensitivity and specificity of CEUS LR-5	6 months	The sensitivity and specificity are calculated.

Countries

China

Contacts

Primary ContactXiang Jing, MD

dr.jingxiang@aliyun.com02284112323

Backup ContactYan Zhou, MD

zhouyan2626@163.com02284118101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026