NCT04954417

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MSCT image

Scanning of the vertebral body using MSCT

Diagnostic Test: Radiological scanningOther: Deep learningProcedure: Bio-mechanical testing

micro-CT image

Scanning of the vertebral body using micro-CT

Diagnostic Test: Radiological scanning

Interventions

Radiological scanningDIAGNOSTIC_TEST

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.

MSCT imagemicro-CT image

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.

MSCT image

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.

MSCT image

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The specimens for this experiment were obtained from formalin-fixed human cadavers.The donors had dedicated their body for educational and research purposes to the local Institute of Anatomy prior to death, in compliance with local institutional and legislative requirements.

You may qualify if:

  • 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) .

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The vertebral specimens for this experiment were obtained from formalin-fixed human cadavers.The donors had dedicated their body for educational and research purposes to the local Institute of Anatomy prior to death, in compliance with local institutional and legislative requirements.

MeSH Terms

Conditions

Osteoporosis

Interventions

Deep Learning

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Machine LearningArtificial IntelligenceAlgorithmsMathematical ConceptsNeural Networks, Computer

Study Officials

  • huishu Yuan

    Department of Radiology Peking University Third Hospital Beijing, China,

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

May 1, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations