- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06540742
Multimodal Imaging Diagnosis and Decision Aid System for Hepatic Echinococcosis Based on Image Omics and Vision Macromodel
September 13, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Hepatic echinococcosis (hepatic echinococcosis) is an important zoonotic disease widely existing in the agricultural and pastoral areas of northwest China.
The disease can be parasitic in any part of the human body and may affect multiple organs.
In severe cases, patients will lose the ability to work.
At present, the disease faces challenges in diagnostic accuracy, specific type identification, preoperative activity assessment, postoperative recurrence prediction, and decision evaluation of T-tube indentation.
This problem is particularly significant in high incidence areas with uneven distribution of medical resources and shortage of excellent imaging physicians and clinicians.
Our previous studies have demonstrated that the use of visual large models and imaging omics algorithms can effectively segment liver echinococcus lesions, extract key features, and provide clinicians with accurate and reliable diagnosis and treatment recommendations.
We believe that on the basis of the transformation of different medical image modes (such as MRI, CT and ultrasound) based on a broader multicentre large data set, the goal of effective identification, diagnosis, surgical decision support, and postoperative accurate prediction of hepatic echinococcosis can be achieved.
We will use artificial intelligence technology solutions such as adversarial generation network, vision large model, image omics and decision level fusion, taking into account diagnosis and treatment efficiency, diagnosis and treatment automation and interpretability of diagnosis results, to build a comprehensive accurate diagnosis and prognosis system for hepatic echinococcosis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Automatic recognition/Efficient diagnosis of hepatic Echinococcosis: Development of a deep learn-based AI diagnostic tool aimed at improving the differentiation of hepatic echinococcosis from other liver diseases such as liver cysts, liver abscesses, and other hepatic cystic space occupying lesions. The tool will utilize generative adversarial networks and polarized self-attention algorithms to effectively identify and classify hepatic echinococcosis to make up for the uneven medical resources and shortage of professional physicians in the western region
- Differential diagnosis of specific types of hepatic echinococcosis: To explore the use of multimodal imaging combined with deep learning methods to distinguish CL type, CE1 type and hepatic cyst of hepatic echinococcosis. This research will apply DINOv2 medical image segmentation algorithm and deep learning technology to accurately identify cases with relatively unevenly distributed and complex data.
- Prediction of postoperative recurrence of hepatic echinococcosis: Transfer learning and Deep-SVDD algorithm are used to predict the risk of postoperative recurrence of hepatic echinococcosis, providing an effective solution for unbalanced sample size data sets. In addition, by integrating the data on the medical big data platform, an AI-based postoperative recurrence prediction model was established
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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China/Guangdong
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Guangzhou, China/Guangdong, China
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
In this study, based on the image data of patients with liver hydatid confirmed by pathology after surgery, deep learning technology was used to distinguish liver hydatid from hepatic cystic station lesions such as liver cyst and liver abscess
Description
Inclusion Criteria:
- Patients with complete original images in CT, ultrasound, and MRI dcim formats
- Patients with liver hydatid confirmed by pathology after operation
- Patients with complete clinical data preservation
Exclusion Criteria:
- Patients with poor quality imaging data
- Patients with incomplete clinical data
- CE4 and CE5 liver hydatid patients diagnosed by imaging alone without surgical treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observation group
In this study, preoperative image data of patients with hepatic hydatid were taken as the research object
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Artificial neural network was constructed to automatically identify liver hydatid by using deep learning technology
|
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Control group
Hepatic cyst, hepatic abscess and normal liver were the control group
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Artificial neural network was constructed to automatically identify liver hydatid by using deep learning technology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
roc curve
Time Frame: 2024.7-2026.3
|
Receiver operating characteristic curve
|
2024.7-2026.3
|
|
AUC
Time Frame: 2024.7-2026.3
|
Area under the ROC curve
|
2024.7-2026.3
|
|
PPV
Time Frame: 2024.7-2026.3
|
Positive Predictive Value
|
2024.7-2026.3
|
|
NPV
Time Frame: 2024.7-2026.3
|
Negative Predictive Value
|
2024.7-2026.3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yajin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2023
Primary Completion (Actual)
September 12, 2024
Study Completion (Actual)
September 12, 2024
Study Registration Dates
First Submitted
August 2, 2024
First Submitted That Met QC Criteria
August 2, 2024
First Posted (Actual)
August 6, 2024
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 13, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSKY-2024-517-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Relevant medical image data involves patient privacy, and the research group refused to share it
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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