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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | January 20, 2025 |
| Trial ID | NCT06684418 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
- Study coordinator: Zhengfei Zhu, PhD
- Email: fuscczzf@163.com
- Phone: +86-18017312901
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.