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

Osteoporosis Clinical Trial

Official title:

A Study on Vertebral Bone Strength by Micro-CT-Like Image: An Approach Based on Conditional Generative Adversarial Nets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954417
• Other study ID #: M2021179
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Dan Jin
• Phone: +8613161525366
• Email: jindan1418[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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) .

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Diagnostic Test:
• Radiological scanning
The collected specimens subject to normalized Micro-CT and MSCT image acquisition, image reconstruction using standard algorithms, and bone structure observation using bone algorithms to obtain high-quality, standardized axial images.

Other:
• Deep learning
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.

Procedure:
• Bio-mechanical testing
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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistency or correlation	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	From the beginning of the experiment to 8 months