Clinical trial NCT06957678: AI-Based Prediction of Lymph Node Metastasis in Gastric Cancer Using Preoperative Multimodal Data
Official title: Artificial Intelligence-Based Prediction of Lymph Node Metastasis and Nodal Station Involvement in Gastric Cancer Using Preoperative Multimodal Imaging and Pathology Data
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastric Cancer Adenocarcinoma Metastatic
Lymph Node Metastasis
Artificial Intelligence (AI) in Diagnosis
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
Collaborators: name: Renmin Hospital of Wuhan University
name: Nanjing University School of Medicine
name: Baoding First Central Hospital
name: Hengshui People's Hospital
name: No.1 Hospital of Shijiazhuang City
name: The Second Affiliated Hospital of Xingtai Medical College
First posted: 2025-05-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll adult patients diagnosed with gastric adenocarcinoma who are scheduled to undergo curative-intent gastrectomy with lymphadenectomy. Participants must have completed preoperative imaging studies and histopathological evaluation. All enrolled patients will have individually retrieved lymph nodes evaluated by detailed pathological examination to provide a definitive reference for lymph node metastasis status.

Brief summary: 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.


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

Primary outcomes:
measure: Diagnostic Accuracy of the AI Model in Predicting Presence of Lymph Node Metastasis in Gastric Cancer
timeFrame: From Preoperative Evaluation to Completion of Postoperative Pathological Analysis (Approximately 4-6 Weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the Fourth Hospital of Hebei Medical University
state: None Selected
Study officials:
References: