Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- NSCLC Cohort
- description
- Patients with pathologically confirmed NSCLC who underwent standard preoperative 18F-FDG PET/CT examination.
Primary outcomes (3)
- measure
- Diagnostic Performance for TNM Staging and Histological Subtyping
- timeFrame
- Baseline
- description
- 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).
- measure
- Predictive Accuracy for EGFR Mutation Status
- timeFrame
- Baseline
- description
- Assessed by the AUC, Sensitivity, and Specificity of the radiomics model in discriminating EGFR mutation status (positive vs. negative) compared to genetic testing results.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available