- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635006
Application of Multitask Deep Learning Model in Grading the Severity of Spinal Facet Joint Degeneration
Study Overview
Status
Intervention / Treatment
Detailed Description
This project is a retrospective clinical study. From 2020 to 2022, DICOM-format images and basic information of X-ray, CT, and magnetic resonance (MR) images were collected from outpatients and inpatients with suspected low back pain at the Fifth Affiliated Hospital of Sun Yat-sen University. After obtaining the DICOM image mode, data were exported from the information module upon the successful submission of OA batches; basic patient information was collected from inpatient medical records.
This study plans to include 1,132 patients from a single center, who will be randomly divided into a training set, a validation set, and a test set according to the proportion for automatic diagnosis by the computer deep learning model, aiming to test the stability and reliability of the model. Among these 1,132 patients, two doctors separately conducted graded image reading for joint stenosis, hypertrophy, osteophytes, articular surface erosion, and subchondral cysts. Controversial results were determined by another more experienced doctor, and results of the reference standard group were confirmed by the senior doctor group. The data analysis methods for other centers were consistent with those described above.
By comparing the diagnostic results of clinicians and the model, the performance and clinical feasibility of the deep learning model for the automatic diagnosis of lumbar facet joint degeneration were evaluated. The doctors' judgment results were compared with the model's prediction results, and statistical analysis was performed on the performance of the model's automatic diagnosis. Performance evaluation indicators included accuracy, sensitivity, specificity, precision, recall, F1 score, and AUC value. Among them, F1 score and AUC value are the main indicators for the comprehensive evaluation of model performance; the higher their values, the stronger the model performance.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Guangdong
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Zhuhai, Guangdong, China
- The fifth affiliated hospital of SYSU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- From 2020 to 2023, data of patients receiving lumbar imaging examination in the Fifth Affiliated Hospital of Sun Yat sen University and other hospital.
Exclusion criteria: patients with conditions like spondylolysis, lumbar spondylolisthesis, lumbar spine fractures, previous lumbar surgery, or severe scoliosis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Training group
70% of the participants were randomly divided into training groups to train the learning performance of the machine
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Validation group
15% of the participants were randomly divided into validation groups to enhance the learning performance of the machine and avoid over fitting
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Test group
15% of the participants were randomly divided into test groups to test the learning performance of the machine and draw research conclusions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To compare the accuracy of multitask deep learning model and clinicians in judging spinal facet joint degeneration
Time Frame: 2022.12.01-2023.07.31
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It is mainly used to indicate the number of correctly predicted samples in the total number of samples.True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Accuracy = (TP + TN) / (TP + FN + FP +TN)
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2022.12.01-2023.07.31
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To compare the precision of multitask deep learning model and clinicians in judging spinal facet joint degeneration
Time Frame: 2022.12.01-2023.07.31
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True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Precision = TP / (TP+FP)
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2022.12.01-2023.07.31
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To compare the sensitivity of multitask deep learning model and clinicians in assessing spinal facet joint degeneration
Time Frame: 2022.12.01-2023.07.31
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True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Sensitivity=TP / (TP+FN)
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2022.12.01-2023.07.31
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To compare the specificity of multitask deep learning model and clinicians in assessing spinal facet joint degeneration
Time Frame: 2022.12.01-2023.07.31
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True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Specificity=TN / (TN+FP)
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2022.12.01-2023.07.31
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Calculate the F1 score for evaluating the severity of facet joints degeneration in the multitask deep learning model
Time Frame: 2022.12.01-2023.07.31
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F1 score is an important evaluation indicator for automatic classification,F1 =2*Precision*Sensitivity/(Precision+Sensitivity)=2TP/(2TP+FP+FN)
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2022.12.01-2023.07.31
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ROC (Receiver Operation Characteristic) is called receiver operation characteristic curve, which is an index to evaluate the performance of deep learning model
Time Frame: 2022.12.01-2023.07.31
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ROC (Receiver Operation Characteristic) is called receiver operation characteristic curve.
The closer the curve is to the upper left corner, the better the classifier is.
The area under the ROC curve is called AUC.
The larger the AUC is, the better the classification effect of the classifier will be.
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2022.12.01-2023.07.31
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZDWY.JZWK.004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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