Clinical trial Recruiting at 1 site Observational Ages 18 and up

AI model to predict hidden lymph node cancer in lung patients

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: A Multicenter, Prospective, Observational Study

Run by Fudan University · NCT06684418 · Data updated 2026-11-12

This study is testing a new AI tool to see if it can find hidden cancer in lymph nodes for people with early-stage lung cancer to help doctors make better treatment choices.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment6000 (estimated)
SponsorFudan University
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 1, 2025
Study endsJune 30, 2026
Registry record updatedJanuary 20, 2025
Trial IDNCT06684418 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with pathologically confirmed early-stage non-small cell lung cancer who have undergone primary radical surgery or stereotactic body radiation therapy.

Probably not a fit

Patients with poor quality imaging, pure ground-glass nodules, or those with uncontrolled epilepsy or mental disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This nationwide, multicenter observational study aims to develop and validate an artificial intelligence (AI) model designed to detect occult lymph node metastasis in patients with early-stage non-small cell lung cancer (NSCLC). The study addresses the challenge of undetected lymph node metastasis, which affects treatment decisions in a significant percentage of cases. By utilizing deep learning techniques to analyze imaging features alongside clinical data, the study seeks to enhance clinical decision-making and improve patient outcomes. Insights gained may also reveal biological mechanisms underlying lymph node metastasis in NSCLC.

Why it matters

Potential benefit: If successful, this study could lead to improved detection of hidden lymph node metastasis, allowing for more informed treatment decisions for NSCLC patients.

How similar studies have gone: Other studies utilizing AI for cancer detection have shown promising results, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fudan university Shanghai Cancer Center
    Shanghai, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.