A Study to Evaluate Chang Gung Pneumothorax Detection Software

• Conditions: Pneumothorax
• Interventions: Device: Chang Gung Pneumothorax Detection Software

• Registration Number: NCT05903209
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

Detailed Description

This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format.

Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.

Study Timeline

• Study Start: 2022-06-13
• Status Verified: 2023-05
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Primary Completion: 2023-12-15
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Study Completion: 2024-01-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• The case were over 20 years old and under 100 years old.
• DICOM format.
• Brand model of Canon.
• DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
• poster-anterior view(PA-view) of chest X-ray

Exclusion Criteria

• The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
• The chest X-ray that are difficult to interpret due to poor image quality.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Software diagnosis	Chang Gung Pneumothorax Detection Software	Software diagnosis with gold standard of 3 doctors' interpretation.

Primary Outcome Measures

Name	Time	Method
Sensitivity	baseline	The rate of test results that correctly indicate the presence.

Secondary Outcome Measures

Name	Time	Method
Specificity	baseline	The rate of test results that correctly indicate the absence.
Area Under the receiver operating characteristic Curve	baseline	A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.

Trial Locations

Locations (1)

Chang Gung memorial hospital; 🇨🇳 Taoyuan City, Taiwan