Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for HCC
NCT ID: NCT04920214
Last Updated: 2021-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2021-01-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS
NCT04955119
Role of CEUS as a Secondary Diagnostic Modality
NCT04494022
Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
NCT05360420
Clinical Application of Quantitative Major Imaging Features of CEUS LI-RADS
NCT06590948
Radiomics Analysis of Focal Liver Lesions Based on Contrast-Enhanced Ultrasound Imaging
NCT04682886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
1. patients with hepatic focal lesions
2. patients with non-high risk factors for hepatocellular carcinoma
SonoVue
CEUS examination was performed and corresponding image information of liver lesions was obtained.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SonoVue
CEUS examination was performed and corresponding image information of liver lesions was obtained.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Non-HCC high-risk patients (hepatitis B, cirrhosis)
Exclusion Criteria
* Patients with solid liver tumors could not be found by conventional imaging;
* Patients who do not sign informed consent;
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Third Central Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
Jining First People's Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
Beijing Hospital
OTHER_GOV
Red Cross Hospital, Hangzhou, China
OTHER
Zhejiang Cancer Hospital
OTHER
Shengjing Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pintong Huang
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Shengjing Hospital
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Jining No.1 People's Hospital
Jining, Shandong, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Peile Jin
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Junhong Ren
Role: primary
Lina Tang
Role: primary
Weidong Ren
Role: primary
Chengrong Mi
Role: primary
Na Feng
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-1010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.