Clinical trial Recruiting at 1 site Observational Ages 18 to 85

AI-assisted CT detection and staging of stomach cancer

Official title: Langue and Imaging-integrated Foundation Model for Gastric Cancer Detection and Staging Via Contrast-Enhanced CT: a Multicenter Study

Run by The First Affiliated Hospital with Nanjing Medical University · NCT07250347 · Data updated 2026-11-12

This project will test an AI tool that reads routine contrast-enhanced CT scans to detect stomach cancer and assign T1–T4 and N0–N3 stages before surgery.

More Gastric Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment8000 (estimated)
SponsorThe First Affiliated Hospital with Nanjing Medical University
Academic / other
Locations1 site (Nanjing, Jiangsu)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedDecember 30, 2028
Study endsDecember 30, 2028
Registry record updatedNovember 26, 2025
Trial IDNCT07250347 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with pathologically confirmed gastric cancer who have preoperative contrast-enhanced CT and proceed to curative-intent gastrectomy with complete postoperative histopathology available.

Probably not a fit

Patients with distant metastases, prior treatment before surgery, or nondiagnostic/poor-quality CT scans are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with pathologically confirmed gastric cancer who undergo pre-treatment contrast-enhanced CT and curative-intent surgery will be enrolled. The AI will analyze routine clinical CECT images to detect tumors and assign four-class T stage and N stage, and its outputs will be compared to surgical pathology supplemented by clinical follow-up. Radiologists will interpret scans with and without AI assistance in a prespecified reader study to measure changes in diagnostic accuracy, interpretation time, and inter-reader agreement. The primary outcomes are detection performance and multi-class staging accuracy (including AUC), with secondary outcomes including reader impact and cross-site reproducibility.

Why it matters

Potential benefit: If successful, the AI could improve preoperative staging accuracy and help doctors choose the right extent of surgery or need for neoadjuvant therapy.

How similar studies have gone: Previous AI studies for CT-based tumor detection and staging have shown promising results, but robust, multi-center validation for four-class T/N staging and reader-assist workflows remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
    Recruiting

Study contacts

  • Principal investigator: Zhang Yudong — The First Affiliated Hospital with Nanjing Medical University
  • Study coordinator: Zhang Yudong, PHD, MD
  • Email: zhangyd3895@njmu.edu.cn
  • Phone: +8618251966069

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.