Automatic Diagnosis of Spinal Stenosis on CT

• Conditions: Spinal Stenosis
• Interventions: Diagnostic Test: deep learning

• Registration Number: NCT03746561
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis.

Detailed Description

MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis. It would be a time-saving workflow if the software can assist the radiologists to detect and locate the suspected lesion.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-16
• Last Update Submitted: 2018-11-16
• Study First Posted: 2018-11-19
• Last Update Posted: 2018-11-19
• Primary Completion: 2019-04
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age >18 years
• with radiologists' CT reports on cervical, thoracic and lumbar stenosis

Exclusion Criteria

• not applicable (only specific levels with extensive infections, fractures, tumor, high-grade spondylolisthesis would be excluded for analysis).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
spinal stenosis	deep learning	Spinal stenosis is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the lower back and the neck.

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of deep learning	1 day	Diagnostic accuracy of deep learning to determine spinal stenosis compared with radiologists' labels based on CT

Secondary Outcome Measures

Name	Time	Method
Diagnostic Performance of deep learning	1 day	Sensitivity, specificity, positive predictive value and negative predictive value of deep learning compared with radiologists' labels based on CT