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OpenTrials
Completed

NCT Number: NCT06602674

PET/CT-Based Image Analysis and Machine Learning of Hypermetabolic Pulmonary Lesions

First, we analyse the types, imaging findings and relevant treatment responses based on PET/CT to complete a more comprehensive view of pulmonary lymphomas.

Then, some models based on radiomics features will be developed to verify the possibility of differentiating pulmonary lymphomas via machine learning and develop a multi-class classification model.

The final objective of this study is to develop a set of deep learning models for preliminary lung lesion segmentation and multi-class classification. The models will classify FDG-avid lung lesions into four groups, each defined by their pathological origin, primary therapy and relevant clinical department.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

  • The local image feature extraction software (LIFEx, v 7.4.0, France) was employed for the image review and measurement of relevant data. Three observers independently interpreted the images. In cases of disagreement, the opinion of a senior doctor with over a decade of experience was given precedence. The imaging findings were recorded based on the baseline examinations. Lesion counts, locations, and descriptive labels were systematically logged in accordance with the norms set out in imaging report. The statistical software SPSS (v26.0) was used in data sorting and calculation. Chi-square test was employed to compare SPL and PPL based on categorical variables like CT findings, while T-test was used to assess continuous variables like glycemia and SUV. Given the predominance of categorical variables, chi-square, or Fisher's exact test (for samples <40 or >20% cells with <5 expected counts) was utilised to assess treatment response and imaging performance. Spearman's correlation coefficient was employed to analyse the relationship between categorical and SUV-based continuous variables.
  • In this study, the metabolic tumor volume at a relative threshold of 40% (MTV40%) was selected as the volume of interest (VOI) for image analysis. For feature extraction, we employed the Python (v3.11.7)-based radiomics feature extraction toolkit PyRadiomics (v3.1.0), along with the medical image processing library SimpleITK (v2.3.1), the numerical computation and data manipulation library Numpy (v1.26.2), and the wavelet transform library PyWavelet (v1.5.0). Feature selection was conducted using RStudio (v.2023.12.0+369) based on the R programming language (v4.2.0). To ensure computational efficiency and avoid overfitting, the number of features retained was limited to 10% or less of the number of lesions in the training set. Model analysis and validation were primarily performed using RStudio as well.
  • The deep learning study divides the task of identifying and classifying hypermetabolic lung lesions into two stages: segmentation and classification. In the segmentation stage, we first utilized the open-source 2D model Lungmask to automatically crop the lung region from whole-body PET/CT images, ensuring that subsequent processing is focused on the lung area. Next, we developed a 3D UNet model with residual modules specifically designed for segmenting hypermetabolic lung lesions. This model takes the cropped PET/CT images as input, efficiently extracting lesion information from the three-dimensional images and accurately segmenting the hypermetabolic lung lesion areas.The model was then applied to both internal test sets and external validation sets for inference, resulting in the extraction of lesion-containing ROIs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years);
  • Primary or recurrent lymphoma, ≥6 months from last treatment; primary lung cancer patients without prior malignancy;
  • Benign solid lung lesions, without prior malignancy;
  • Pulmonary metastasis, untreated with lung radiotherapy or particle implantation;
  • Baseline assessment revealing PET-positive pulmonary lesions.
  • Pathological results within 3 months of exam date, confirmed lung lesion types via tracheoscopy, lung puncture, or surgery.
  • Baseline pulmonary lesions remaining considered to be pulmonary lymphoma (or metastases) based on follow-up clinical and imaging evaluation.

Exclusion criteria

  • Poor image quality;
  • Inability to delineate the boundaries of lung lesions on CT images;
  • Artifacts caused by nearby devices such as stents or drainage tubes.

Treatment and study plan

Observe the medical images

Other

Observe the medical images via work station or local image analysing software

Feature extraction

Other

Extracting image feature via radiomics or deep learning methods

Primary outcomes

  1. Imaging/radiomics/deep learning features of 18F-FDG PET/CT image

    Time frame: Baseline

Secondary outcomes

  1. Efficiency of the segmentation model

    Time frame: immediately after the development and testing of models

    The effectiveness of the segmentation model is evaluated by the detection rate of lesions and the Dice similarity coefficient (2(A∩B)/ (A+B), A=segmented voxel volume, B=ground truth volume), which both describes the accuracy of dividing the lesion and the background.

  2. Efficiency of the classification model

    Time frame: immediately after the development and testing of models

    The classification model is evaluated by the accuracy [ (TP+TN)/(TP+FP+TN+FN) ] , precision [TP/(TP+FP)], recall [TP/(TP+FN)], F1-score [2*precision*recall/(precision+recall)], which all describes the ratio of correctly or wrongly classified lesions of the samples from different aspects. While the receiver operating characteristic (ROC) curve can illustrate this more visuelly. Area under the curve (AUC) calculated the proportion of area under the ROC curve, ranging from 0 to 1, representing the overall efficiency of classification in each group.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Jiangsu Province Hospital of Traditional Chinese Medicine
  • Luan people's hospital
  • Ruijin North Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China

Registry information

Official study title

PET/CT Imaging-Based Distinction of Pulmonary Lymphoma and Other Hypermetabolic Lesions Via Imaging Manifestations and Machine Learning Techniques: a Multicenter Retrospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 23, 2025

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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