Evaluation of the Accuracy and Effectiveness of the AccuPulmo CT Portal AI-Assisted Interpretation System for the Diagnosis of Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Sensitivity of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis
研究概览
简要总结
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.
详细描述
This is a single-center, retrospective, non-interventional diagnostic performance study using pre-existing chest computed tomography images and associated clinical information from Taichung Veterans General Hospital.
Eligible participants are adults aged 20 years or older who underwent chest computed tomography for pulmonary disease between January 1, 2020, and December 31, 2024. The study plans to include 900 chest computed tomography examinations, comprising approximately 300 pulmonary fibrosis-positive examinations and 600 pulmonary fibrosis-negative examinations.
Potentially eligible examinations will initially be identified from existing institutional radiology records. Images with missing data or image characteristics that substantially interfere with lung texture assessment, including cardiac implants, extensive pneumonia, or pleural effusion, will be excluded according to the prespecified eligibility criteria.
Before specialist review, positive and negative samples will be combined, de-identified, assigned blinded study codes, and randomly allocated for review. Three qualified specialists holding board certification in pulmonology or radiology will independently evaluate all study images. The specialists will not have access to participant identifiers, the original radiology reports, or the AccuPulmo CT Portal results. Each specialist will estimate the proportion of pulmonary fibrosis and classify each examination as pulmonary fibrosis positive or negative. The reference standard will be determined by majority agreement, defined as concordant classification by at least two of the three specialists.
All coded images will subsequently be analyzed by AccuPulmo CT Portal. According to the prespecified classification rule, a pulmonary fibrosis area greater than 10 percent will be classified as positive, designated as Critical Risk, whereas a pulmonary fibrosis area of 10 percent or less will be classified as negative, designated as Low Risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pulmonary Fibrosis-Positive Cases
Participants with pre-existing chest computed tomography examinations selected as potentially positive for pulmonary fibrosis based on available institutional radiology records. Final pulmonary fibrosis status for the performance analysis will be determined by majority agreement of at least two of three blinded specialists in pulmonology or radiology.
干预措施: AccuPulmo CT Portal (Device)
Pulmonary Fibrosis-Negative Controls
Participants with pre-existing chest computed tomography examinations selected as potentially negative for pulmonary fibrosis based on available institutional radiology records. Final pulmonary fibrosis status for the performance analysis will be determined by majority agreement of at least two of three blinded specialists in pulmonology or radiology.
干预措施: AccuPulmo CT Portal (Device)
结局指标
主要结局
Sensitivity of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis
时间窗: Baseline
Sensitivity is defined as the proportion of pulmonary fibrosis-positive examinations according to the specialist-derived reference standard that are correctly classified as positive by AccuPulmo CT Portal. The reference standard is determined by majority agreement of at least two of three blinded specialists. A pulmonary fibrosis area greater than 10 percent generated by AccuPulmo CT Portal is classified as positive. Sensitivity will be reported with a 95 percent confidence interval and evaluated against the prespecified performance threshold of 0.80 using a one-sided binomial test.
Specificity of AccuPulmo CT Portal for Detecting Pulmonary Fibrosis
时间窗: Baseline
Specificity is defined as the proportion of pulmonary fibrosis-negative examinations according to the specialist-derived reference standard that are correctly classified as negative by AccuPulmo CT Portal. The reference standard is determined by majority agreement of at least two of three blinded specialists. A pulmonary fibrosis area of 10 percent or less generated by AccuPulmo CT Portal is classified as negative. Specificity will be reported with a 95 percent confidence interval and evaluated against the prespecified performance threshold of 0.80 using a one-sided binomial test.
次要结局
- Diagnostic Accuracy of AccuPulmo CT Portal(Baseline)
- Positive Predictive Value of AccuPulmo CT Portal(Baseline)
- Negative Predictive Value of AccuPulmo CT Portal(Baseline)
- Sensitivity and Specificity Across Prespecified Clinical Subgroups(Baseline)
研究者
Pin-Kuei Fu, MD, PhD
Director, Division of Clinical Trials
Taichung Veterans General Hospital