Retrospective Validation of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis on Chest CT (NCT07761377) | Clinical Trial Compass
RecruitingNot Applicable
Retrospective Validation of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis on Chest CT
Taiwan900 participantsStarted 2025-10-15
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Availability of sufficient image information to permit blinded specialist assessment of pulmonary fibrosis
Exclusion Criteria:
* 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
* Pleural effusion that substantially interferes with lung texture assessment
* Other image abnormalities or artifacts that preclude reliable evaluation of pulmonary fibrosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis
Timeframe: Baseline
2
Specificity of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis