Actively Recruiting

Age: 18Years +
All Genders
NCT06684418

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

Led by Fudan University · Updated on 2025-01-20

6000

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed non-small cell lung cancer
  • Clinical stage I (AJCC, 8th edition, 2017)
  • Age 18 years or older
  • Karnofsky Performance Status (KPS) score of 70 or higher
  • Patients who have undergone primary NSCLC radical surgery or stereotactic body radiotherapy (SBRT)
  • Complete systemic lesion imaging assessment before primary NSCLC radical surgery or SBRT (PET/CT and/or invasive mediastinal staging required for tumors 2 3 cm or centrally located tumors)
  • Patients willing to cooperate with follow-up after primary NSCLC treatment
  • Informed consent provided by the patient
Not Eligible

You will not qualify if you...

  • 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 that may interfere with consent or compliance
  • Loss to follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan university Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

Z

Zhengfei Zhu, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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