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

NCT07449858 | Active Not Recruiting DMC

• 1 other identifier: 2025-0690
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Non Small Cell Lung Cancer

Keywords

18F-FDG PET/CT; Radiomics; Artificial Intelligence; EGFR Mutation; Prognosis

Outcome Measures

Primary Outcomes (3)

• Diagnostic Performance for TNM Staging and Histological Subtyping

  Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC), Sensitivity, and Specificity of the radiomics model in predicting T-stage, N-stage, and histological subtypes (ADC vs. SCC).

  Baseline

• Predictive Accuracy for EGFR Mutation Status

  Assessed by the AUC, Sensitivity, and Specificity of the radiomics model in discriminating EGFR mutation status (positive vs. negative) compared to genetic testing results.

  Baseline

• Prognostic Value

  Evaluation of Disease-Free Survival (DFS) and Overall Survival (OS). DFS is defined as time to recurrence or death. OS is defined as time to death from any cause.

  From date of surgery up to 5 years

Study Arms (1)

NSCLC Cohort

Patients with pathologically confirmed NSCLC who underwent standard preoperative 18F-FDG PET/CT examination.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically confirmed Non-Small Cell Lung Cancer (NSCLC) who underwent standard preoperative whole-body 18F-FDG PET/CT examinations at The Second Affiliated Hospital of Zhejiang University School of Medicine and other participating tertiary hospitals.

You may qualify if:

• Age \>= 18 years.
• Underwent standard whole-body 18F-FDG PET/CT scan within 30 days before surgery.
• Histopathologically confirmed Non-Small Cell Lung Cancer (NSCLC) with clear histological subtyping and complete postoperative TNM staging.
• Primary tumor SUVmax \> 2.5 and maximum diameter \> 1.0 cm on CT.
• Complete clinical, pathological, and imaging data available.
• (For Gene Sub-study) Known EGFR gene mutation status.
• (For Prognosis Sub-study) Complete follow-up data available (minimum 12 months or until endpoint event).

You may not qualify if:

• History of other malignancies.
• Received any anti-tumor treatment (chemotherapy, radiotherapy, targeted therapy, immunotherapy) prior to PET/CT.
• Severe image artifacts or indistinct tumor boundaries affecting ROI delineation.
• Missing key clinical or pathological data.
• Baseline PET/CT evaluated recurrent or metastatic tumors instead of primary NSCLC.
• Extremely short life expectancy due to severe comorbidities.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First Hospital of China Medical University: collaborator
• West China Hospital: collaborator
• Guangdong Second Provincial General Hospital: collaborator

Study Sites (4)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaohui Zhang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

CN (4)