AI-Assisted Detection and Staging of Gastric Cancer Using Contrast-Enhanced CT

NCT07250347 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Observational

Started

2025-08-01

Last updated

2025-11-26

Condition(s) studied

Gastric Cancer StageGastric Cancer Patients Undergoing Gastrectomy

Investigational drug(s) / intervention(s)

CT scan

CT scan: preoperative contrast-enhanced CT

Study summary

Accurate preoperative assessment of gastric cancer stage guides eligibility for endoscopic resection, extent of gastrectomy and lymphadenectomy, selection for neoadjuvant therapy, and use of staging laparoscopy. Contrast-enhanced CT (CECT) is guideline-endorsed for initial staging, yet performance varies across institutions and readers. This study will evaluate an artificial-intelligence (AI) system that analyzes routine CECT to detect gastric cancer and assign four-class T stage (T1-T4) and N stage (N0-N3) .

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: 1. pathologically confirmed gastric cancer; 2. preoperative contrast-enhanced CT performed; 3. no evidence of distant metastasis on baseline staging; 4. curative-intent management with complete postoperative histopathology. Exclusion Criteria: 1. prior treatment before surgery; 2. non-diagnostic or poor-quality CT precluding evaluation.

Primary outcome measure(s)

Diagnostic performance of the AI model for staging — 3 years
The primary outcome is the diagnostic accuracy of the AI system for four-class T staging (T1-T4) and N staging (N0-3) based on contrast-enhanced CT. The AI performance will be assessed using accuracy, area under the receiver operating characteristic curve (AUC), and micro-AUC for internal and external cohorts.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07250347 on ClinicalTrials.gov ↗ ← All trials in China