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NCT Number: NCT07449858

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic Performance for TNM Staging and Histological Subtyping

    Time frame: 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).

  2. Predictive Accuracy for EGFR Mutation Status

    Time frame: 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.

  3. Prognostic Value

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • First Hospital of China Medical University
  • Guangdong Second Provincial General Hospital
  • West China Hospital

Registry information

Official study title

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

Acronym: PET-Rad-NSCLC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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