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Clinical Trials in China / NCT06947096
Enrolling by invitation Observational

Radiomics-Based AI Model for Predicting Para-Aortic Lymph Node Metastasis in Gastric Cancer Patients

NCT06947096 · tracked via the Priya Life Science China tracker
Sponsor
Qun Zhao
Phase
Observational
Started
2025-01-01
Last updated
2025-04-27

Condition(s) studied

Gastric CancerPara-Aortic Lymph Node MetastasisLymphatic MetastasisPreoperative Imaging AssessmentRadiomicsArtificial Intelligence

Investigational drug(s) / intervention(s)

Radiomics-Based AI Imaging Analysis

Radiomics-Based AI Imaging Analysis: This intervention involves the development and application of a radiomics-based artificial intelligence (AI) model to analyze preoperative abdominal CT images of patients with gastric cancer. The AI algorithm extracts high-dimensional imaging features from the para-aortic region to predict the presence or absence of para-aortic lymph node metastasis (PALNM). This non-invasive method aims to assist clinicians in preoperative risk stratification and treatment planning. The model will be trained and validated using manually segmented lymph node regions and correlated with postoperative pathological findings to ensure accuracy and clinical relevance.

Study summary

This study aims to develop and validate an artificial intelligence (AI) model based on radiomics features extracted from preoperative CT images to predict para-aortic lymph node (PALN) metastasis in patients with gastric cancer. Accurately identifying PALN metastasis before surgery can help doctors make better treatment decisions, such as whether to proceed with surgery, consider chemotherapy, or use other treatment strategies. The study will prospectively enroll patients who are diagnosed with gastric cancer and scheduled for surgery. All participants will undergo routine imaging tests, and their data will be analyzed using advanced AI techniques. The results of this study may improve the precision of preoperative staging and support personalized treatment planning for gastric cancer patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adults aged 18-80 years. 2. Histologically confirmed gastric adenocarcinoma. 3. Planned to undergo radical gastrectomy with or without para-aortic lymph node dissection. 4. Preoperative contrast-enhanced abdominal CT scan available within 3 weeks before surgery. 5. No evidence of distant metastasis on imaging. 6. ECOG performance status 0-2. 7. Provided written informed consent. Exclusion Criteria: 1. History of other malignant tumors within the past 5 years. 2. Received neoadjuvant chemotherapy or radiotherapy prior to CT imaging. 3. Poor-quality or incomplete CT images not suitable for radiomics analysis. 4. Severe comorbidities that may affect prognosis or surgical decision-making. 5. Pregnancy or breastfeeding. 6. Inability to provide informed consent or comply with study procedures.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the Fourth Hospital of Hebei Medical University Shijiazhuang None Selected

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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 NCT06947096 on ClinicalTrials.gov ↗ ← All trials in China