Lung Cancer
Conditions
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.
Interventions
DEVICEAided read with InferRead Lung CT.AI
Radiologists read chest CT scans with the aid of InferRead Lung CT.AI
Sponsors
Infervision
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Lung cancer screening eligible patients
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed