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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fudan university Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Zhengfei Zhu, PhD
fuscczzf@163.com
+86-18017312901
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 6000
Treatments
Retrospective Cohort
Enrolling about 5,000 early-stage NSCLC patients from January 2018 to June 2024 across 25 centers in China, data including chest CT scans and clinicopathological parameters will be used to train and validate the AI model. Patients will be divided into high-risk and low-risk groups based on the model's risk score, and clinical benefits of treatments like lymph node dissection, adjuvant therapy, and SBRT will be analyzed.
Prospective Cohort
Enrolling 1,000 patients from November 2024 to October 2025, this cohort will prospectively validate the AI model's performance and explore the biological basis of metastasis by analyzing pathological tissues, RNA sequencing, and tumor immune microenvironment characteristics.
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov