Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2025-07-01
Last updated
2026-03-04
Condition(s) studied
Non Small Cell Lung Cancer
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Diagnostic Performance for TNM Staging and Histological Subtyping — Baseline 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).
Predictive Accuracy for EGFR Mutation Status — Baseline Assessed by the AUC, Sensitivity, and Specificity of the radiomics model in discriminating EGFR mutation status (positive vs. negative) compared to genetic testing results.
Prognostic Value — From date of surgery up to 5 years 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.
Trial sites (4)
Facility
City
Region
Status
Guangdong Second Provincial General Hospital
Guangzhou
Guangdong
The First Hospital of China Medical University
Shenyang
Liaoning
West China Hospital of Sichuan University
Chengdu
Sichuan
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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