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Enrolling by invitation NCT06957678

AI-Based Prediction of Lymph Node Metastasis in Gastric Cancer Using Preoperative Multimodal Data

Observational Gastric Cancer Adenocarcinoma Metastatic Lymph Node Metastasis Artificial Intelligence (AI) in Diagnosis

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artificial Intelligence-Based Predictive Model for Lymph Node Metastasis.
Who it may be relevant to
Registry conditions: Gastric Cancer Adenocarcinoma Metastatic, Lymph Node Metastasis, Artificial Intelligence (AI) in Diagnosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Artificial Intelligence-Based Prediction of Lymph Node Metastasis and Nodal Station Involvement in Gastric Cancer Using Preoperative Multimodal Imaging and Pathology Data

Overview

This study aims to develop and validate an artificial intelligence (AI) system that can predict whether lymph node metastasis has occurred in patients with gastric cancer before surgery. Using preoperative imaging and pathology data, the AI models will not only predict if metastasis is present but also identify which specific lymph node stations or individual lymph nodes are involved. All lymph nodes will be carefully removed during surgery and examined one by one with detailed pathological methods to ensure accurate diagnosis. The goal is to improve the accuracy of lymph node assessment and assist doctors in making better treatment decisions.

Interventions

  • Diagnostic test Artificial Intelligence-Based Predictive Model for Lymph Node Metastasis
    The intervention is an artificial intelligence-based predictive model developed using preoperative multimodal data, including contrast-enhanced CT images, preoperative histopathological findings, and clinical features. The model is designed to predict (1) the presence or absence of lymph node metastasis, (2) the specific lymph node stations involved, and (3) the individual lymph nodes involved. Each lymph node's metastatic status is confirmed by serial pathological sectioning of surgically retri

Primary outcome measures

  • Diagnostic Accuracy of the AI Model in Predicting Presence of Lymph Node Metastasis in Gastric Cancer [Time frame: From Preoperative Evaluation to Completion of Postoperative Pathological Analysis (Approximately 4-6 Weeks)]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older

Histologically confirmed gastric adenocarcinoma

Scheduled for curative-intent gastrectomy with lymphadenectomy

Completed preoperative imaging with contrast-enhanced CT or MRI

Available preoperative biopsy pathology report

Able and willing to provide written informed consent

Exclusion criteria

  • Evidence of distant metastasis on preoperative imaging

Prior chemotherapy, radiotherapy, or major abdominal surgery

Severe comorbidities contraindicating surgery

Incomplete or poor-quality preoperative imaging or pathology data

Pregnancy or lactation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the Fourth Hospital of Hebei Medical University — Shijiazhuang

Identifiers

NCT: NCT06957678 · GC-RAD-AI-2025-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗