Clinical trial · Observational
AI Model for Early Gastric Cancer Diagnosis Using Endoscopic Imaging
Development and Validation of an Explainable Artificial Intelligence Model for Early Gastric Cancer Diagnosis Using Multimodal Endoscopic Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Early Gastric Cancer
- description
- Participants with histopathologically confirmed early gastric cancer who underwent endoscopic examination, including white-light imaging and image-enhanced endoscopy.
- interventionNames
- Other: No intervention (observational study)
- label
- Non-Early Gastric Lesions
- description
- 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.
- interventionNames
- Other: No intervention (observational study)
Primary outcomes (1)
- measure
- Diagnostic performance of the artificial intelligence model for detecting early gastric cancer
- timeFrame
- Up to 14 days after endoscopy, when histopathological results are available
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available