Utility of Ultrasound Imaging for Diagnosis of Focal Liver Lesions: A Radiomics Analysis

Intelligent Diagnosis of Focal Liver Lesions and Thermal Ablation Zone of Liver Cancer Based on Ultrasound Imaging

Ultrasound (US) as first-line imaging technology in detecting focal liver lesions,also plays a crucial role in evaluating image and guiding ablation which is the main treatment for liver lesions. However, the effect of US in diagnosing liver lesions is challenged by several factors including being highly dependent on doctor's experience, low signal-to-noise ratio, low resolution for lesion feature,large error from thermal field evaluation during the process of ablation and so on. Therefore, it is of great significance to construct an intelligent US analysis system depending on the digital information technology. Basing on these problems,the following research will be involved in our project: 1) US database of liver lesions with seamless connection to Picture Archiving and Communication Systems (PACS) will be developed, with the aim to provide standard data for intelligent US analysis. 2) Deep learning model for accurate segmentation, detection and classification of liver lesions on US images will be studied. Then automatic extraction, selection and analysis of liver lesion ultrasound features and the intelligent US diagnosis for liver lesions will be realized. 3) Proposing a clustering model with deep image features, and depicting the similarity measurement of liver cancer, which can be furthered used to link the liver cancer feature to optimal ablation parameters. The intelligent decision-making system for quantifying thermal ablation will be established. 4) Regression algorithm and Generative Adversarial Nets will be developed to extract the image features of liver cancer which will predict risk factors after US-guided thermal ablation.Based on the above researches, it is of great value to establish an intelligent focal liver lesion US diagnosis system involving intelligent diagnosis,personalized ablation strategy and accurate prognosis evaluation, improving the level of accurate diagnosis and treatment of liver lesions.

Study Overview

• Status: Unknown
• Conditions: Ablation; Radiomics; Focal Liver Lesions; Ultrasonics; Intelligent Diagnosis
• Intervention / Treatment: Other: diagnosis

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Jie Yu, Dr; Phone Number: 15901417963; Email: jiemi301@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with focal liver lesions

Description

Inclusion Criteria:

1. clear ultrasound imaging of focal liver lesions including malignant liver tumors such as hepatocellular carcinoma, metastatic liver cancer and benigh liver tumors such as hemangioma and focal nodular hyperplasia and so on can be acquired.
2. clear ultrasound imaging of liver tissues backgroud without lesions can be acquired.
3. disease history and pathological diagnosis of the lesions can be acquired.

Exclusion Criteria:

1. patients unsuitable for ultrasound san
2. patients counldn't provide disease history such as hepatitis, alcohol intake and so on
3. patients without pathological results

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity	diagnosis sensitivity of intelligent ultrasound analysis	through study completion, an average of 3 year
AUC value	Area under the receiver operating characteristic (ROC) curve (AUC）	through study completion, an average of 3 year
specificity	diagnosis specificity of intelligent ultrasound analysis	through study completion, an average of 3 year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 301jrcsk3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No