AI tool to predict lymph node spread and support doctors' decisions in early (T1) stomach cancer
Development and Validation of a Multimodal Artificial Intelligence Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer and Its Impact on Physician Diagnostic Performance
This study will test whether an AI that combines clinical information, pathology slides, and CT scans can predict lymph node spread in adults with T1 gastric cancer and help doctors of different experience levels make better treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hebei Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shijiazhuang, None Selected) |
| Trial ID | NCT07124754 on ClinicalTrials.gov |
What this trial studies
This observational study will develop and validate a multimodal deep-learning model that integrates clinical variables, preoperative CT imaging, and histopathology slides to predict lymph node metastasis in patients with T1 gastric adenocarcinoma. Model training and internal validation will use data from adults who underwent radical gastrectomy with lymph node dissection at the Fourth Hospital of Hebei Medical University, excluding cases with poor-quality or missing imaging or prior neoadjuvant therapy. The protocol includes a physician-reader component to compare diagnostic performance with and without AI assistance across clinicians with varying levels of experience. Findings are intended to inform preoperative decision-making about whether less invasive or more extensive surgical management is appropriate for early gastric cancer.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed primary T1 (T1a or T1b) gastric adenocarcinoma who have preoperative clinical data, CT scans, and pathology slides and who underwent or will undergo radical gastrectomy with lymph node dissection and provided consent.
Not a fit: Patients with distant metastases (M1), prior other malignancies within five years, who received neoadjuvant chemo/radiotherapy, who lack complete or good-quality preoperative imaging/pathology data, or who decline consent are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the AI could help identify patients who can safely avoid extensive lymph node surgery or who need more aggressive treatment, reducing unnecessary procedures and personalizing care.
How similar studies have performed: AI models using imaging or pathology data have shown promise in cancer staging and supporting physician readers, but fully integrated multimodal models specifically predicting lymph node metastasis in T1 gastric cancer remain relatively novel and not widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 18 years or older Histologically confirmed primary gastric adenocarcinoma Clinical stage T1 (T1a or T1b) confirmed by endoscopy and imaging Undergoing radical gastrectomy with lymph node dissection Preoperative data available: clinical variables, CT imaging, and pathology slides Written informed consent provided Exclusion Criteria: History of other malignancies within the past 5 years Received neoadjuvant chemotherapy or radiotherapy Incomplete clinical or pathological data Poor quality or missing CT or histopathology images Patients with distant metastasis (M1) at diagnosis Inability or refusal to provide informed consent
Where this trial is running
Shijiazhuang, None Selected
- the Fourth Hospital of Hebei Medical University — Shijiazhuang, None Selected, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.