Clinical Validation of InferRead Lung CT.AI
- Conditions
- Lung Cancer
- Registration Number
- NCT04119960
- Lead Sponsor
- Infervision
- Brief Summary
Lung cancer is the second most common cause of cancer-related death in men and women. Early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of lung cancer. Early lung cancer screening has been investigated and applied as a medical practice. InferRead Lung CT.AI by Infervision is a dedicated post processing application that generates CADe marks as an overlay on the original CT series intended to aid the radiologist in the detection of pulmonary nodules. This study was designed to evaluate radiologists' performance in detecting actionable nodules on chest CT when aided by InferRead.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Lung cancer screening eligible patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection accuracy 20 hours The primary objective of this clinical study is to demonstrate that a radiologist review of a CT scan aided with InferRead Lung CT.AI significantly improves detection of actionable lung nodules. Area under the ROC curve, Sensitivity, specificity, PPV, NPV will be reported, compared between unaided and aided reads.
- Secondary Outcome Measures
Name Time Method Reading time change 20 hours The secondary objective of this clinical study is to demonstrate that the radiologist's review time is not significantly increased when aided with InferRead Lung CT.AI. The reading time for each case will be recorded in both aided and unaided reads. The reading times will be compared using a paired T test.
Trial Locations
- Locations (1)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States