About this trial
This retrospective observational study evaluates the diagnostic performance of AccuPulmo CT Portal, an artificial intelligence-assisted medical imaging software, for detecting pulmonary fibrosis on pre-existing chest computed tomography images.
A total of 900 chest computed tomography examinations obtained at Taichung Veterans General Hospital between January 1, 2020, and December 31, 2024, will be retrospectively selected. The planned sample includes 300 examinations with pulmonary fibrosis and 600 examinations without pulmonary fibrosis.
All study images will be de-identified and coded before evaluation. Three qualified specialists in pulmonology or radiology will independently review each image without access to the original radiology report or the artificial intelligence output. The reference standard will be established by majority agreement of at least two of the three specialists.
AccuPulmo CT Portal will retrospectively analyze the coded images. An artificial intelligence-derived pulmonary fibrosis area greater than 10 percent will be classified as positive, and an area of 10 percent or less will be classified as negative. The primary performance measures are sensitivity and specificity. Secondary measures include accuracy, positive predictive value, negative predictive value, and performance across clinically relevant subgroups.
The software results will not be returned to treating physicians and will not affect participant diagnosis, treatment, or clinical management.
Eligibility criteria
Qualifiers
Participants aged 20 years or older at the time of the chest computed tomography examination
Participants who underwent chest computed tomography for pulmonary disease at Taichung Veterans General Hospital between January 1, 2020, and December 31, 2024
Availability of a completed clinical radiology report
Availability of chest computed tomography images suitable for de-identification and analysis by AccuPulmo CT Portal
Disqualifiers
Missing or incomplete chest computed tomography images
Image quality insufficient for pulmonary fibrosis assessment
Cardiac implants or other devices that substantially interfere with lung texture assessment
Extensive pneumonia that substantially interferes with lung texture assessment
Trial design
Treatments tested in this trial
- AccuPulmo CT Portal
Treatment groups
Sponsors and collaborators
Taichung Veterans General Hospital
Lead sponsor
V5med Inc.
Collaborator