RecruitingNCT06684418

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

Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer: A Multicenter, Prospective, Observational Study

Sponsor

Fudan University

Enrollment

6,000 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses artificial intelligence (AI) to predict whether lung cancer has secretly spread to nearby lymph nodes in people with early-stage non-small cell lung cancer (NSCLC), to help doctors make better treatment decisions. **You may be eligible if...** - You have been confirmed to have non-small cell lung cancer (NSCLC) - Your cancer is clinical stage I (early, localized) - You are 18 years or older - You have already had or are about to have surgery or radiation (SBRT) to treat the primary tumor - You have had a complete imaging evaluation of the cancer before treatment **You may NOT be eligible if...** - Your CT scan images are poor quality - Your scan shows a pure "ground glass" appearance (a specific imaging pattern) - You have uncontrolled epilepsy, brain disease, or mental health issues that would affect your ability to consent or cooperate - You are unable to be followed up after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTchest enhanced CT

This is an observational study and patients will receive routine clinical treatment according to the corresponding guidelines. We will collect the enrolled patient's chest enhanced CT and clinicopathological parameters.