An observational study in Compression Fracture, sponsored by Taipei Medical University WanFang Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Taipei Medical University WanFang Hospital · Observational
This project aims to develop and validate an automatic detection and classification system for vertebral compression fractures on computer tomography (CT) images using an artificial intelligence (AI) system (named Smart Bone) by Quanta.
A computer search of CT scans (2010.01.01-2018.09.30) was performed in Wan Fang Hospital. Those CT images that were retrospectively reviewed by experienced radiologists. The CT scans of 1000-1500 subjects aged 50 and above with and without thoracic or lumbar compression fractures were included in this project for machine learning and deep learning. The control group included those without compression fractures while the patient group were those with compression fractures. Subjects that did not meet the inclusion criteria were excluded.
The cortical layer of the T12-L5 spine images were manually labelled with the labeling software by the the technologists and confirmed the correctness of the image by an experienced radiologist. All the de-linked and completed images were provided to Quanta Computer Inc. for subsequent classification and analysis of AI machines for deep learning to facilitate the development of a system for automatic detection of pressure fractures by CT. This newly developed automatic system will be of valuable clinical impact in assisting radiologists to detect and classify vertebral compression fractures precisely and accurately.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 100 across 16 observational studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Taipei Medical University WanFang Hospital is the lead sponsor of 201 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 1000-1500 subjects were recruited in both sex, aged 50 and above, and who had come to Wan Fang Hospital for CT scans, including those with or without vertebral compression fractures as the compression fractures group and the control group respectively.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A computer search of CT scans (2010.01.01-2018.09.30) was performed in Wan Fang Hospital. These CT images were retrospectively reviewed by an experienced radiologist who classified and marked with annotations of vertebral fractures by the Genant's semiquantitative method.
The same CT images were separately reviewed and processed by the artificial intelligence system (Smart Bone) by Quanta for compression fractures. The two results, one by the radiologists and the other by artificial intelligence system, will be compared to statistically quantify equivalence (CADe).
Other: Computer Assisted Detection Software For Vertebral Fractures
A device named Smart Bone that is using CT image retrospectively acquired to entails a second review of CT images with Vertebral Compression Fractures through an interactive AI program developed by Quanta Computer Inc. was applied to the CT images. The device is a computer-aided detection (CADe) software application and is designed to assist radiologists to analyze Spine CT images. The device uses deep learning methods to perform vertebrae detection and classification of images.
Also known as: Smart Bone
Concordance rate
CT Imaging Reporting and Data System descriptors suggested by Smart Bone are in good agreement with those selected by experts. In other words, the CT Imaging Reporting and Data System generated by Smart Bone are not statistically different from the consensus of experts. CT Imaging Reporting and Data System Assessment Category Score: The user makes the final decision on the Assessment Category Score. Using this Score, Smart Bone displays the assessment description. Grade 0: Normal Vertebrae Grade 1: Mild Fracture, 20-25% Grade 2: Moderate Fracture, 26-40% Grade 3: Severe Fracture, \>40%
Time frame: 2019.06 to 2020.03
Accuracy
Comparing to the accuracy of CT imaging results by radiologists with and without CADe will be evaluated.
Time frame: 2019.06 to 2020.03
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Taipei Medical University WanFang Hospital →