NCT06684418Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6000 (estimated)
- First submitted
- 11 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT06684418
What you commit to
- Study type: Observational
- Planned participants: 6000
- From 1 Dec 2024 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.;
Other
- Poor quality of computed tomography imaging;
- Baseline imaging shows pure ground-glass nodules (GGO);
- Loss to follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.