Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07551466

Development and Validation of an Explainable Artificial Intelligence Model for Early Gastric Cancer Diagnosis Using Multimodal Endoscopic Imaging

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-24

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating an explainable multimodal artificial intelligence (AI) model to improve the diagnosis of early gastric cancer (EGC) using endoscopic imaging. The study addresses challenges in accurately detecting EGC due to subtle features and variability among endoscopists. The goal is to develop a reliable AI tool that combines multiple imaging types and clinical data, enhancing diagnostic accuracy and interpretability during endoscopic examinations. The study collects data from patients who underwent endoscopic submucosal dissection (ESD) with confirmed early gastric cancer or non-cancerous lesions. It uses white-light imaging (WLI) and image-enhanced endoscopy to gather representative images. The process includes developing a lesion detection model, extracting quantitative image features, and using deep learning to analyze images. These features are integrated with clinical information to build a multimodal AI prediction model. Participants provide endoscopic images and clinical data, which are divided into training, validation, and testing groups for model evaluation. The AI model's diagnostic performance is measured using metrics like the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, and accuracy. The study also applies methods to explain and visualize the AI's decision-making process, aiming to support clinical use of AI-assisted diagnosis. Evaluation occurs up to 14 days after endoscopy when histopathological results are available.

CONDITIONS

Brief Title

AI Model for Early Gastric Cancer Diagnosis Using Endoscopic Imaging

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age  18 years
  • Suspicious gastric lesions identified on white-light imaging (WLI)
  • Preoperative biopsy indicating precancerous lesions (dysplasia or intraepithelial neoplasia) or adenocarcinoma
  • Preoperative magnifying endoscopy with narrow-band imaging (ME-NBI) performed
  • Patients who meet absolute indications for endoscopic submucosal dissection (ESD) and have undergone ESD
Not Eligible

You will not qualify if you...

  • Non-adenocarcinoma histological types (e.g., lymphoma)
  • Patients who did not undergo ME-NBI examination or did not receive ESD
  • Lesions invading the muscularis propria or deeper layers
  • Missing or indeterminate postoperative histopathological results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 14 days after endoscopy

Participants undergo endoscopic examination including white-light imaging and image-enhanced endoscopy to identify and assess gastric lesions.

1 visit (in-person)

Long-term Monitoring

Duration - Up to several months as data is collected and analyzed

Participants who have undergone endoscopic submucosal dissection are observed as their imaging and clinical data are collected for AI model development and validation.

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, China

Actively Recruiting

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Research Team

L

Li he Liu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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