Radiomics Analysis of Focal Liver Lesions Based on Contrast-Enhanced Ultrasound Imaging

NCT04682886 | Unknown

• 1 other identifier: 82030047
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast-enhanced ultrasound (CEUS) substantially improves the potential of ultrasound (US) for the identification and characterization of focal liver lesions (FLLs). Compared to contrasted-enhanced MRI and CT, it has some unique advantages, such as the absence of ionizing radiation, and easy operability and repeatability. However, the efficacy of CEUS in diagnosing liver lesions is challenged by several factors including being highly dependent on doctor's experience, low signal-to-noise ratio, and low interobserver agreement. Therefore, it is a beneficial attempt to construct an intelligent CEUS diagnosis system using digital information technology. This study aims to collect standard data of CEUS cines recordings and develop deep learning model for accurate segmentation, detection and classification of liver lesions.

Conditions

Focal Liver Lesions; Contrast-enhanced Ultrasound

Outcome Measures

Primary Outcomes (3)

• AUC value

  Area under the receiver operating characteristic (ROC) curve (AUC）

  through study completion, an average of 7 year

• specificity

  diagnosis specificity of intelligent CEUS analysis

  through study completion, an average of 7 year

• sensitivity

  diagnosis sensitivity of intelligent ultrasound analysis

  through study completion, an average of 3 year

Interventions

diagnosis DIAGNOSTIC_TEST

there is no intervention diagnosis or treatment for patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with focal liver lesions

You may qualify if:

• patients with a solid liver tumor visible during routine ultrasound and received CEUS.
• disease history and standard of reference of the lesions can be acquired

You may not qualify if:

• hypersensitivity for ultrasound contrast media
• pregnant or lactating patients
• previously treated lesions or local relapse from previously treated lesions
• diffuse tumors

Sponsors & Collaborators

• Ping Liang: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (3)

• Ding W, Li B, Zhao L, Zheng L, Li X, Liu S, Yu J, Liang P. Improving Detection of Intrahepatic Cholangiocarcinoma with a Contrast-enhanced US-based Deep Learning Model. Radiol Imaging Cancer. 2025 Nov;7(6):e250078. doi: 10.1148/rycan.250078.

  PMID: 41236388 DERIVED

• Wu J, Liu S, Zhang Y, Ding W, Zhao Q, Wang Y, Xiao F, Yu X, Xie X, Liu S, Zhao J, Liao J, Yu J, Liang P. Prediction of Macrotrabecular-Massive Hepatocellular Carcinoma and Associated Prognosis Using Contrast-enhanced US and Clinical Features. Radiol Imaging Cancer. 2025 Jul;7(4):e240419. doi: 10.1148/rycan.240419.

  PMID: 40607931 DERIVED

• Ding W, Meng Y, Ma J, Pang C, Wu J, Tian J, Yu J, Liang P, Wang K. Contrast-enhanced ultrasound-based AI model for multi-classification of focal liver lesions. J Hepatol. 2025 Aug;83(2):426-439. doi: 10.1016/j.jhep.2025.01.011. Epub 2025 Jan 21.

  PMID: 39848548 DERIVED

MeSH Terms

Interventions

Diagnosis

Central Study Contacts

Jie Yu, Dr

CONTACT

15901417963; jiemi301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

CN (1)