跳至主要内容
临床试验/NCT07551466
NCT07551466招募中不适用

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

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Diagnostic performance of the artificial intelligence model for detecting early gastric cancer

研究概览

简要总结

Early gastric cancer (EGC) is often difficult to detect accurately during endoscopic examination due to subtle morphological features and variability among endoscopists. Artificial intelligence (AI) has shown promise in improving diagnostic performance; however, most existing models lack interpretability and rely on single-modality imaging.

This study aims to develop and evaluate an explainable multimodal artificial intelligence model for the diagnosis of early gastric cancer using endoscopic imaging. The model integrates features derived from white-light imaging and image-enhanced endoscopy, along with quantitative image features and clinical data, to improve diagnostic accuracy and provide interpretable decision support.

The primary outcome is the diagnostic performance of the AI model for detecting early gastric cancer, evaluated by area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity.

The results of this study are expected to provide evidence for the clinical utility of explainable AI in endoscopic diagnosis and support the development of reliable human-AI collaborative diagnostic systems.

详细描述

This study is designed to develop and evaluate an explainable multimodal artificial intelligence (AI) model for the diagnosis of early gastric cancer (EGC) based on endoscopic imaging.

Patients who underwent endoscopic submucosal dissection (ESD) will be collected from one or more medical centers. Eligible patients will include those with histopathologically confirmed early gastric cancer or non-cancerous lesions who have undergone both white-light imaging (WLI) and image-enhanced endoscopy. For each lesion, representative endoscopic images will be selected according to predefined quality criteria.

The study will be conducted in several steps. First, a lesion detection model will be developed to identify regions of interest in endoscopic images. Second, quantitative image features, including color, texture, morphological, and mucosal structural features, will be extracted from the detected regions. Third, deep learning models will be used to derive predictive features from both WLI and image-enhanced endoscopic images. These features will be integrated with clinical variables to construct a multimodal prediction model.

The dataset will be divided into training, validation, and testing subsets. Model performance will be evaluated using standard diagnostic metrics, including the area under the receiver operating characteristic curve (AUROC), accuracy, sensitivity, specificity, and F1 score. Calibration performance and clinical utility may also be assessed using calibration curves and decision curve analysis.

To enhance model interpretability, feature contribution will be analyzed using Shapley additive explanations (SHAP), and visualization techniques such as gradient-weighted class activation mapping (Grad-CAM) will be applied to highlight regions of interest contributing to model predictions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Suspicious gastric lesions identified on white-light imaging (WLI)
  • Preoperative biopsy indicating precancerous lesions (dysplasia or intraepithelial neoplasia) or adenocarcinoma, with preoperative magnifying endoscopy with narrow-band imaging (ME-NBI) performed
  • Patients meeting the absolute indications for endoscopic submucosal dissection (ESD) and who underwent ESD

排除标准

  • 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

研究组 & 干预措施

Early Gastric Cancer

Participants with histopathologically confirmed early gastric cancer who underwent endoscopic examination, including white-light imaging and image-enhanced endoscopy.

干预措施: No intervention (observational study) (Other)

Non-Early Gastric Lesions

Participants with non-cancerous gastric lesions or non-early gastric cancer confirmed by histopathology who underwent endoscopic examination, including white-light imaging and image-enhanced endoscopy.

干预措施: No intervention (observational study) (Other)

结局指标

主要结局

Diagnostic performance of the artificial intelligence model for detecting early gastric cancer

时间窗: Up to 14 days after endoscopy, when histopathological results are available

The primary outcome is the diagnostic performance of the artificial intelligence model for identifying early gastric cancer, evaluated by the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, accuracy, and F1 score, using histopathological diagnosis as the reference standard.

次要结局

未报告次要终点

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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