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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Diagnostic Performance for TNM Staging and Histological Subtyping
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
NSCLC Cohort
Patients with pathologically confirmed NSCLC who underwent standard preoperative 18F-FDG PET/CT examination.
结局指标
主要结局
Diagnostic Performance for TNM Staging and Histological Subtyping
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点