Hepatocellular CarcinomaNCT04920214
Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for HCC
An observational study of Hepatocellular Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 10 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SonoVue
- How many people
- 500 participants
- Where
- 10 sitesChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. patients with focal liver lesions 2. patients with non-high risk factors for hepatocellular carcinoma
Who may be able to join
- The patient showed focal liver lesions on routine ultrasound examination.
- Non-HCC high-risk patients (hepatitis B, cirrhosis)
Who cannot join
- 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;
Trial locations and contacts
10 sites in 1 country.
Peile Jin contact
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100000
Junhong Ren, 13910813603
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000
Qin Chen, 18981838665, 1718686103@qq.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Lina Tang, 13625079386
Yijie Chen, 13960766160, 19178610@qq.com
- Recruiting
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Pintong Huang, director, +8618857168333, huangpintong@126.com
Peile Jin, collegue, +8619883125285, jinpeile@zju.edu.cn
- Recruiting
Red Cross Hospital, Hangzhou, China
Hangzhou, Zhejiang, 310000
Ying Zhang, zhangying5201@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Dong Xu, 13588341756, xudnj@163.com
Na Feng, 15868808101
- Recruiting
Shandong Jining No.1 People's Hospital
Jining, Shandong, 272000
Long Li, weifanglilong@126.com
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110000
Weidong Ren, 18940251657
- Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300000
Xiang Jiang, 13920111890, dr.jingxiang@aliyun.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000
Chengrong Mi, 13909599333
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SonoVue
- Keywords
- liver, liver imaging, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoVueDiagnostic test
CEUS examination was performed and corresponding image information of liver lesions was obtained.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | 1. patients with hepatic focal lesions
2. patients with non-high risk factors for hepatocellular carcinoma Receives: Diagnostic Test: SonoVue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value
The positive predictive value of LR-5 diagnosis of HCC was compared among different map readers
Measured: 3 years
Negative Predictive Value
The negative predictive value of LR-5 diagnosis of HCC was compared among different map readers
Measured: 3 years
Sensitivity
The sensitivity of LR-5 diagnosis of HCC was compared among different map readers
Measured: 3 years
Specificity
The specificity of LR-5 diagnosis of HCC was compared among different map readers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Third Central Hospital, Sichuan Provincial People's Hospital, Fujian Cancer Hospital, Jining First People's Hospital, General Hospital of Ningxia Medical University, Beijing Hospital, Red Cross Hospital, Hangzhou, China, Zhejiang Cancer Hospital, Shengjing Hospital
- Responsible party
- Sponsor
- Investigators
- Pintong Huang, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920214
- Sponsor's protocol ID
- 2020-1010
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04920214
- Acronym / sponsor ID
- 2020-1010
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver, liver imaging, liver cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Tianjin Third Central Hospital, Sichuan Provincial People's Hospital, Fujian Cancer Hospital, Jining First People's Hospital, General Hospital of Ningxia Medical University, Beijing Hospital, Red Cross Hospital, Hangzhou, China, Zhejiang Cancer Hospital, Shengjing Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Diagnostic Test: SonoVue1. patients with hepatic focal lesions 2. patients with non-high risk factors for hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. patients with focal liver lesions 2. patients with non-high risk factors for hepatocellular carcinoma
Key inclusion criteria (2 listed)
- The patient showed focal liver lesions on routine ultrasound examination.
- Non-HCC high-risk patients (hepatitis B, cirrhosis)
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoVueCEUS examination was performed and corresponding image information of liver lesions was obtained. | Diagnostic test | Experimental group |
Primary outcome
Positive Predictive Value
Time frame: 3 years
The positive predictive value of LR-5 diagnosis of HCC was compared among different map readers
Negative Predictive Value
Time frame: 3 years
The negative predictive value of LR-5 diagnosis of HCC was compared among different map readers
Sensitivity
Time frame: 3 years
The sensitivity of LR-5 diagnosis of HCC was compared among different map readers
Specificity
Time frame: 3 years
The specificity of LR-5 diagnosis of HCC was compared among different map readers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peile Jin contact
Pintong Huang study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pintong Huang (+8618857168333, huangpintong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.