Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer

Fudan University

Status: Enrolling

Conditions: NSCLC (Non-small Cell Lung Cancer); Lymphnode Metastasis; Artificial Intelligence (AI)

Treatments: Diagnostic Test: chest enhanced CT

Study type: Observational

Funder types: Other

Identifiers

NCT06684418

OLNM-AI

Details and patient eligibility

About

This nationwide, multicenter observational study aims to develop and validate a multimodal artificial intelligence (AI) model for detecting occult lymph node metastasis in early-stage non-small cell lung cancer (NSCLC) patients. Despite advances in lymph node staging, 12.9%-39.3% of occult nodal metastasis cases remain undetected preoperatively, affecting treatment decisions. This study will use deep learning to extract imaging features of occult metastasis and combine them with clinical data to build an AI model for risk prediction. This study will provide insights into the feasibility of AI-driven detection of occult metastasis, supporting clinical decision-making and potentially revealing underlying biological mechanisms of lymph node metastasis in NSCLC.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed non-small cell lung cancer;
• Clinical stage I (AJCC, 8th edition, 2017);
• Age≥18 years old;
• KPS score≥70;
• Patients who have undergone primary NSCLC radical surgery or SBRT treatment;
• Complete systemic lesion imaging assessment before primary NSCLC radical surgery or SBRT treatment (Note: Tumor size ≥ 3 cm or centrally located tumor requires PET/CT and/or invasive mediastinal staging);
• Patients willing to cooperate with the follow-up after primary NSCLC radical surgery;
• informed consent of the patient.

Exclusion criteria

• Poor quality of computed tomography imaging;
• Baseline imaging shows pure ground-glass nodules (GGO);
• Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
• Loss to follow-up.

Trial design

6,000 participants in 2 patient groups

Retrospective Cohort

Description:

Enrolling about 5,000 early-stage NSCLC patients from January 2018 to June 2024 across 25 centers in China, data including chest CT scans and clinicopathological parameters will be used to train and validate the AI model. Patients will be divided into "high-risk" and "low-risk" groups based on the model's risk score, and clinical benefits of treatments like lymph node dissection, adjuvant therapy, and SBRT will be analyzed.

Treatment:

Diagnostic Test: chest enhanced CT

Prospective Cohort

Description:

Enrolling 1,000 patients from November 2024 to October 2025, this cohort will prospectively validate the AI model's performance and explore the biological basis of metastasis by analyzing pathological tissues, RNA sequencing, and tumor immune microenvironment characteristics.

Treatment:

Diagnostic Test: chest enhanced CT