NCT07449858

18F-FDG PET/CT Radiomics Models for Precision Diagnosis and Prognosis in NSCLC

Construction and Validation of Precision Diagnosis and Treatment Models for Non-Small Cell Lung Cancer (NSCLC) Based on 18F-FDG PET/CT Radiomics: A Multicenter Retrospective Clinical Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter retrospective study aims to investigate the value of 18F-FDG PET/CT radiomics features in the preoperative precision staging, pathological typing, gene mutation status prediction, and prognostic risk stratification of patients with Non-Small Cell Lung Cancer (NSCLC). The study involves constructing and validating machine learning models to provide imaging-based evidence for individualized precision clinical decision-making.

Detailed description

The study consists of three main parts based on a multicenter retrospective cohort: Staging and Typing: Developing radiomics models to distinguish histological subtypes (Adenocarcinoma vs. Squamous Cell Carcinoma) and predict TNM staging preoperatively. Gene Mutation Prediction: Analyzing radiomics signatures to predict EGFR mutation status (Mutant vs. Wild-type) non-invasively. Prognostic Assessment: Evaluating the prognostic value of radiomics features by analyzing their association with Disease-Free Survival (DFS) and Overall Survival (OS). High-throughput radiomics features will be extracted from standardized PET/CT images and analyzed using machine learning algorithms.

Conditions

• Non Small Cell Lung Cancer

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-03-01
• Completion: 2027-12-31
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

4 sites across 1 country: China