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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682886
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Focal Liver Lesions Contrast-enhanced Ultrasound Diagnostic Test: diagnosis

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research on Key Techniques for Intelligent Diagnosis and Ablation Decision-making of Liver Cancer and Evolution by Contrast-enhanced Ultrasound
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: diagnosis
    there is no intervention diagnosis or treatment for patients

Outcome Measures
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Primary Outcome Measures :
  1. AUC value [ Time Frame: through study completion, an average of 7 year ]
    Area under the receiver operating characteristic (ROC) curve (AUC）

  2. specificity [ Time Frame: through study completion, an average of 7 year ]
    diagnosis specificity of intelligent CEUS analysis

  3. sensitivity [ Time Frame: through study completion, an average of 3 year ]
    diagnosis sensitivity of intelligent ultrasound analysis


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with focal liver lesions
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682886


Contacts
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Contact: Jie Yu, Dr 15901417963 jiemi301@163.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jie Yu, Doctor    8601066939530    jiemi301@163.com   
Sponsors and Collaborators
Ping Liang
More Information
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Responsible Party: Ping Liang, Prof, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04682886    
Other Study ID Numbers: 82030047
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No