Focal Liver LesionsNCT04682886
Radiomics Analysis of Focal Liver Lesions Based on Contrast-Enhanced Ultrasound Imaging
An observational study of Focal Liver Lesions and Contrast-enhanced Ultrasound, run by Ping Liang at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Focal Liver Lesions, Contrast-enhanced Ultrasound
- What is being tested?
- diagnosis
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with focal liver lesions
Who may be able to join
- 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
Who cannot join
- hypersensitivity for ultrasound contrast media
- pregnant or lactating patients
- previously treated lesions or local relapse from previously treated lesions
- diffuse tumors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8601066939530, jiemi301@163.com
About this study
Official title: Research on Key Techniques for Intelligent Diagnosis and Ablation Decision-making of Liver Cancer and Evolution by Contrast-enhanced Ultrasound
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
- Being tested
- diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosisDiagnostic test
there is no intervention diagnosis or treatment for patients
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC value
Area under the receiver operating characteristic (ROC) curve (AUC）
Measured: through study completion, an average of 7 year
specificity
diagnosis specificity of intelligent CEUS analysis
Measured: through study completion, an average of 7 year
sensitivity
diagnosis sensitivity of intelligent ultrasound analysis
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focal Liver LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ping Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682886
- Sponsor's protocol ID
- 82030047
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41236388Wu 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.
PubMed 40607931Ding 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.
PubMed 39848548
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Key Techniques for Intelligent Diagnosis and Ablation Decision-making of Liver Cancer and Evolution by Contrast-enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT04682886
- Acronym / sponsor ID
- 82030047
- Conditions
- Focal Liver Lesions, Contrast-enhanced Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Ping LiangUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with focal liver lesions
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- hypersensitivity for ultrasound contrast media
- pregnant or lactating patients
- previously treated lesions or local relapse from previously treated lesions
- diffuse tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosisthere is no intervention diagnosis or treatment for patients | Diagnostic test | – |
Primary outcome
AUC value
Time frame: through study completion, an average of 7 year
Area under the receiver operating characteristic (ROC) curve (AUC）
specificity
Time frame: through study completion, an average of 7 year
diagnosis specificity of intelligent CEUS analysis
sensitivity
Time frame: through study completion, an average of 3 year
diagnosis sensitivity of intelligent ultrasound analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Derived from this study: PubMed 41236388Ding 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.
- Derived from this study: PubMed 40607931Wu 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.
- Derived from this study: PubMed 39848548Ding 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Liver Lesions and Contrast-enhanced Ultrasound, run by Ping Liang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Dr (15901417963, jiemi301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC value (time frame: through study completion, an average of 7 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682886, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.