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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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
  2. 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.
  3. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • China/Guangdong
      • Guangzhou, China/Guangdong, China
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Patients with complete original images in CT, ultrasound, and MRI dcim formats
  2. Patients with liver hydatid confirmed by pathology after operation
  3. Patients with complete clinical data preservation

Exclusion Criteria:

  1. Patients with poor quality imaging data
  2. Patients with incomplete clinical data
  3. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observation group
In this study, preoperative image data of patients with hepatic hydatid were taken as the research object
Diagnostic test: Artificial intelligence identifies liver hydatids
Artificial neural network was constructed to automatically identify liver hydatid by using deep learning technology
Control group
Hepatic cyst, hepatic abscess and normal liver were the control group
Diagnostic test: Artificial intelligence identifies liver hydatids
Artificial neural network was constructed to automatically identify liver hydatid by using deep learning technology

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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