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

July 14, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Peile Jin
  • Phone Number: +8619883125285

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Hospital
        • Contact:
          • Junhong Ren
          • Phone Number: 13910813603
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Lina Tang
          • Phone Number: 13625079386
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shengjing Hospital
        • Contact:
          • Weidong Ren
          • Phone Number: 18940251657
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Chengrong Mi
          • Phone Number: 13909599333
    • Shandong
      • Jining, Shandong, China, 272000
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Third Central Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Contact:
          • Na Feng
          • Phone Number: 15868808101
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China, 310000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. patients with focal liver lesions
  2. patients with non-high risk factors for hepatocellular carcinoma

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental group
  1. patients with hepatic focal lesions
  2. patients with non-high risk factors for hepatocellular carcinoma
Diagnostic test: SonoVue
CEUS examination was performed and corresponding image information of liver lesions was obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value
Time Frame: 3 years
The positive predictive value of LR-5 diagnosis of HCC was compared among different map readers
3 years
Negative Predictive Value
Time Frame: 3 years
The negative predictive value of LR-5 diagnosis of HCC was compared among different map readers
3 years
Sensitivity
Time Frame: 3 years
The sensitivity of LR-5 diagnosis of HCC was compared among different map readers
3 years
Specificity
Time Frame: 3 years
The specificity of LR-5 diagnosis of HCC was compared among different map readers
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

Investigators

  • Study Chair: Pintong Huang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (ACTUAL)

June 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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