Trials / Recruiting
RecruitingNCT07250347
AI-Assisted Detection and Staging of Gastric Cancer Using Contrast-Enhanced CT
Langue and Imaging-integrated Foundation Model for Gastric Cancer Detection and Staging Via Contrast-Enhanced CT: a Multicenter Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 8,000 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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) .
Detailed description
Adults with confirmed gastric cancer undergoing pre-treatment CECT will be enrolled. The AI analysis will be applied to clinically acquired images. Radiologist interpretations with and without AI support will be collected in a prespecified reader study. The reference standard will include surgical pathology, supplemented by clinical follow-up when applicable. The primary outcome is detection performance, diagnostic performance of the AI for four-class staging (e.g., accuracy and area under the receiver operating characteristic curve). Secondary outcomes include the effect of AI assistance on reader accuracy and interpretation time, inter-reader agreement, and cross-site reproducibility.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | CT scan | preoperative contrast-enhanced CT |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2028-12-30
- Completion
- 2028-12-30
- First posted
- 2025-11-26
- Last updated
- 2025-11-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07250347. Inclusion in this directory is not an endorsement.