NCT04920214

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 15, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

May 30, 2021

Last Update Submit

July 14, 2021

Conditions

Hepatocellular Carcinoma

Keywords

liverliver imagingliver cancer

Outcome Measures

Primary Outcomes (4)

  • Positive Predictive Value

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

    3 years

  • Negative Predictive Value

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

    3 years

  • Sensitivity

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

    3 years

  • Specificity

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

    3 years

Study Arms (1)

Experimental group

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

Diagnostic Test: SonoVue

Interventions

SonoVueDIAGNOSTIC_TEST

CEUS examination was performed and corresponding image information of liver lesions was obtained.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • The patient showed focal liver lesions on routine ultrasound examination.
  • Non-HCC high-risk patients (hepatitis B, cirrhosis)

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Beijing Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Shengjing Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

RECRUITING

Shandong Jining No.1 People's Hospital

Jining, Shandong, 272000, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Red Cross Hospital, Hangzhou, China

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Pintong Huang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY CHAIR

Central Study Contacts

Pintong Huang

CONTACT

+8618857168333huangpintong@126.com

Peile Jin

CONTACT

+8619883125285

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 9, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 15, 2021

Record last verified: 2021-05

Locations

CN(10)