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

Focal Liver Lesions Clinical Trial

Official title:

Research on Key Techniques for Intelligent Diagnosis and Ablation Decision-making of Liver Cancer and Evolution by Contrast-enhanced Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682886
• Other study ID #: 82030047
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2020
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Dr
• Phone: 15901417963
• Email: jiemi301[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. patients with a solid liver tumor visible during routine ultrasound and received CEUS.

2. disease history and standard of reference of the lesions can be acquired

Exclusion Criteria:

1. hypersensitivity for ultrasound contrast media

2. pregnant or lactating patients

3. previously treated lesions or local relapse from previously treated lesions

4. diffuse tumors

Related Conditions & MeSH terms

• Contrast-enhanced Ultrasound
• Focal Liver Lesions

Intervention

Diagnostic Test:
• diagnosis
there is no intervention diagnosis or treatment for patients

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ping Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC value	Area under the receiver operating characteristic (ROC) curve (AUC)	through study completion, an average of 7 year
Primary	specificity	diagnosis specificity of intelligent CEUS analysis	through study completion, an average of 7 year
Primary	sensitivity	diagnosis sensitivity of intelligent ultrasound analysis	through study completion, an average of 3 year