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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

+8619883125285

10 sites in 1 country

China10 sites, 10 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

    Recruiting

Other trials in China

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.

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 groups in NCT04920214
Study groupRoleWhat they receive
Experimental group1. 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.

  1. Positive Predictive Value

    The positive predictive value of LR-5 diagnosis of HCC was compared among different map readers

    Measured: 3 years

  2. Negative Predictive Value

    The negative predictive value of LR-5 diagnosis of HCC was compared among different map readers

    Measured: 3 years

  3. Sensitivity

    The sensitivity of LR-5 diagnosis of HCC was compared among different map readers

    Measured: 3 years

  4. 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.

  1. First posted9 Jun 2021
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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)
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

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.

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