A Study on Vertebral Bone Strength by Micro-CT-Like Image

• Conditions: Osteoporosis
• Interventions: Diagnostic Test: Radiological scanning; Other: Deep learning; Procedure: Bio-mechanical testing

• Registration Number: NCT04954417
• Lead Sponsor: Peking University Third Hospital

Brief Summary

In this study, we use conditional generation adversarial network to enhance the resolution of MSCT images and obtain micro-CT-like images. Based on this, we measure the bone structure indexes of micro-CT-like images and analyzed the correlation between bone structure and bio-mechanical indexes.

Detailed Description

In this study, we expect to collect 10 sets of vertebrae (between T6 and L5) from 10 formalin-fixed human cadavers. The study protocol was reviewed and approved by the local Institutional Review Boards.The collected specimens subject to normalized Micro-CT and MSCT image scanning, image reconstruction using standard algorithms, and bone structure observation using bone algorithms to obtain high-quality, standardized axial images. We will use a conditional generation adversarial network-based image mapping technique to train the mapping model between MSCT images and Micro-CT images, find the correspondence between the image information contained in each of MSCT and Micro-CT, and finally obtain high-resolution micro-CT-like images. After obtaining the Micro-CT-like images of the samples, we will segment and annotate the images (including different structures such as vertebral body, bone cortex) and train the Teacher-Student \& U-Net++ deep learning architecture to achieve accurate segmentation of vertebral body regions, and obtain cancellous bone regions of interest. Based on this, we will analyze the bone structure characteristics of each spatial region in the images, including the thickness, spacing, orientation and distribution pattern of bone trabeculae and other indicators. Ultimately, we will cut a standardized cubic sample from the vertebral cancellous bone , obtain the bio-mechanical performance index of this cancellous bone sample by mechanical experiments, and analyze the correlation between bone structure of Micro-CT-like images and bio-mechanical index.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• We will collect human formalin-fixed vertebral specimens provided by the Department of Anatomy, Peking University School of Medicine. The expected number of enrolled specimens is approximately 100 vertebrae (between T6 and L5) .

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Exclusion Criteria

• The vertebrae with significant compression fractures, bone neoplasms, or other causes of significant bone destruction.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MSCT image	Deep learning	Scanning of the vertebral body using MSCT
MSCT image	Bio-mechanical testing	Scanning of the vertebral body using MSCT
MSCT image	Radiological scanning	Scanning of the vertebral body using MSCT
micro-CT image	Radiological scanning	Scanning of the vertebral body using micro-CT

Primary Outcome Measures

Name	Time	Method
Consistency or correlation	From the beginning of the experiment to 8 months	Analyze the consistency or correlation between micro-CT and micro-CT-like bone structure indexes; analyze the correlation between micro-CT-like bone structure indexes and bio-mechanical indexes

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China