Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920214
• Other study ID #: 2020-1010
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pintong Huang
• Phone: +8618857168333
• Email: huangpintong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently, there are few studies on the diagnostic ability of CEUS-LI-RADS in patients with non-high risk factors for liver nodules. Whether this classification is applicable to such patients remains controversial. There are relatively few studies on the diagnostic efficacy of HCC in clinical diagnosis and the consistency between map readers, and the applicable population is only focused on patients with hepatic fibrosis. Therefore, this study explored the application value of CEUS Li-RADS in liver focal lesions in patients with non-high risk factors for hepatocellular carcinoma.

Description:

According to the latest epidemiological survey in 2018, primary liver cancer is the sixth most common cancer in the world. Among these, hepatocellular carcinoma is the most common type of liver cancer. Clinicians' diagnosis of HCC has been gradually transformed from invasive puncture diagnosis to non-invasive diagnosis based on enhanced imaging findings. In HCC tissue, the number of small blood vessels was increased and the arrangement was disordered. Compared with the surrounding normal liver tissue, there were more obvious manifestations of increased arterial blood supply. Contrast-enhanced Ultrasound (CEUS) is the most sensitive and objective tool for detecting circulatory perfusion, and can achieve a clear and dynamic display of low speed and small blood flow. Its diagnostic efficacy of HCC is similar to the diagnostic ability of Enhanced CT.

In order to better standardize the writing of liver CEUS report by sonographers, and to facilitate sonographers and clinicians to reach a consensus on the diagnosis and treatment of liver lesions, In 2017, the American Radiology College (ACR) released the CEUS-based Liver Imaging Reporting and Data System (CEUS-Li-RADS). At the same time, according to the perfusion methods in the arterial, portal and venous phases, the CEUS-Li-RADS angiographic findings were classified into main features and LR-M features by ACR Association. The former included high enhancement in arterial phase and mild clearance in portal vein phase (after 60S) or delayed phase. The latter includes annular high enhancement, early clearance and complete clearance. In the classification, CEUS Li-RADS was classified into the following categories according to the possibility of HCC diagnosis with different characteristics of CEUS: LR-1 (definitely benign), LR-2 (possibly benign),LR-3 (possibly HCC), LR-4 (highly suspected HCC), LR-5 (confirmed HCC), and LR-M (liver malignant lesion, not specifically HCC).

In January 2018, Professor Bruix, Chairman of AASLD, wrote in the journal Heaptology that a qualified LIRADS classification should meet the following requirements :(1) LIRADS classification should focus on high-risk groups for HCC; (2) In LI-RADS classification, the specificity of LR-5 in the diagnosis of HCC should be close to 100%; (3) There is a good consistency between the main evaluation criteria of LI-RADS classification, LR-M evaluation criteria and the readers of final classification.

Currently, there are few studies on the diagnostic ability of CEUS-LI-RADS in patients with non-high risk factors for liver nodules. Whether this classification is applicable to such patients remains controversial. There are relatively few studies on the diagnostic efficacy of HCC in clinical diagnosis and the consistency between map readers, and the applicable population is only focused on patients with hepatic fibrosis. Therefore, this study explored the application value of CEUS Li-RADS in liver focal lesions in patients with non-high risk factors for hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient showed focal liver lesions on routine ultrasound examination.

• Non-HCC high-risk patients (hepatitis B, cirrhosis)

Exclusion Criteria:

• High-risk patients with HCC (hepatitis B, cirrhosis);

• Patients with solid liver tumors could not be found by conventional imaging;

• Patients who do not sign informed consent;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• SonoVue
CEUS examination was performed and corresponding image information of liver lesions was obtained.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Red Cross Hospital, Hangzhou, China	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong Jining No.1 People's Hospital	Jining	Shandong
China	Shengjing Hospital	Shenyang	Liaoning
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (10)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Beijing Hospital, Fujian Cancer Hospital, General Hospital of Ningxia Medical University, Red Cross Hospital, Hangzhou, China, Shandong Jining No.1 People's Hospital, Shengjing Hospital, Sichuan Provincial People's Hospital, Tianjin Third Central Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Predictive Value	The positive predictive value of LR-5 diagnosis of HCC was compared among different map readers	3 years
Primary	Negative Predictive Value	The negative predictive value of LR-5 diagnosis of HCC was compared among different map readers	3 years
Primary	Sensitivity	The sensitivity of LR-5 diagnosis of HCC was compared among different map readers	3 years
Primary	Specificity	The specificity of LR-5 diagnosis of HCC was compared among different map readers	3 years