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临床试验/NCT07306858
NCT07306858尚未招募不适用

A Deep Learning Model Based on CT Images for Differentiating Acute and Chronic Osteoporotic Vertebral Compression Fractures

Xin Fan1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2025年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
276
试验地点
1
主要终点
Diagnostic performance of the deep learning model for differentiating acute and chronic osteoporotic vertebral compression fractures

研究概览

简要总结

Osteoporotic vertebral compression fractures are common in older adults and may present as either acute or chronic fractures. Correctly distinguishing acute from chronic fractures is clinically important because treatment strategies and management decisions differ depending on fracture chronicity. However, differentiating acute and chronic osteoporotic vertebral compression fractures based on imaging findings alone can be challenging in routine clinical practice.

This retrospective study aims to develop an intelligent diagnostic system based on computed tomography (CT) images to differentiate acute and chronic osteoporotic vertebral compression fractures. Clinical and imaging data from patients diagnosed with osteoporotic vertebral compression fractures will be collected from the First Affiliated Hospital of Chongqing Medical University and an additional medical center. A deep learning model will be trained to automatically analyze CT images and classify fractures as acute or chronic.

The results of this study may help improve the accuracy and efficiency of fracture chronicity assessment using CT images and provide supportive information for clinical decision-making regarding treatment selection in patients with osteoporotic vertebral compression fractures.

详细描述

This study is a retrospective, multicenter observational study designed to develop and evaluate a deep learning-based system for differentiating acute and chronic osteoporotic vertebral compression fractures using computed tomography (CT) images.

Patients diagnosed with osteoporotic vertebral compression fractures who underwent both CT and magnetic resonance imaging (MRI) examinations will be retrospectively collected from the First Affiliated Hospital of Chongqing Medical University and one additional medical center between January 2023 and September 2025. Clinical data, including age, sex, and dual-energy X-ray absorptiometry (DXA) results, as well as complete DICOM-format CT and MRI images, will be collected. The interval between CT and MRI examinations must be less than two weeks. Patients with pathological fractures caused by infection or tumor, the presence of foreign materials such as bone cement or metallic hardware, or poor image quality with significant artifacts will be excluded.

The study workflow includes data collection, model development, performance evaluation, and model interpretability analysis. Multiple deep learning segmentation models, including U-Net, U-Mamba, and UNETR++, will first be evaluated for vertebral body segmentation performance. Based on the optimal segmentation results, classification models such as VGG-16, DenseNet-121, Vision Transformer (ViT), and Transformer-based architectures will be trained to differentiate acute and chronic compression fractures. The best-performing model will be selected to construct the final classification system.

Model performance for segmentation tasks will be assessed using Dice similarity coefficient and loss values. Classification performance will be evaluated in an external validation dataset using area under the receiver operating characteristic curve (AUC), sensitivity, specificity, accuracy, positive predictive value, and negative predictive value. Receiver operating characteristic curves and confusion matrices will be generated to visualize model performance.

To improve model interpretability, gradient-weighted class activation mapping (Grad-CAM) will be applied to generate heatmaps highlighting image regions that contribute most to model predictions. These heatmaps will be overlaid on CT images to visually demonstrate how the model differentiates acute and chronic osteoporotic vertebral compression fractures.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Patients diagnosed with osteoporotic vertebral compression fractures.
  • Patients who underwent both CT and MRI examinations of the spine, with an interval of less than 2 weeks between examinations.
  • Availability of complete CT and MRI imaging data in DICOM format.
  • Availability of complete clinical information, including age, sex, and dual-energy X-ray absorptiometry (DXA) results.
  • Age 50 years or older at the time of imaging.

排除标准

  • Vertebral compression fractures caused by infection or malignancy.
  • Presence of foreign materials, including bone cement or metallic hardware.
  • Poor image quality or significant imaging artifacts that affect analysis.

结局指标

主要结局

Diagnostic performance of the deep learning model for differentiating acute and chronic osteoporotic vertebral compression fractures

时间窗: At the time of image analysis

The diagnostic performance of the deep learning model in differentiating acute and chronic osteoporotic vertebral compression fractures based on CT images, evaluated using the area under the receiver operating characteristic curve (AUC).

次要结局

未报告次要终点

研究者

发起方
Xin Fan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin Fan

Professor

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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