Clinical Validation of InferRead Lung CT.AI
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|ClinicalTrials.gov Identifier: NCT04119960|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment|
|Lung Cancer||Device: Aided read with InferRead Lung CT.AI|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Clinical Validation of InferRead Lung CT.AI|
|Actual Study Start Date :||January 10, 2019|
|Actual Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||October 30, 2019|
- Device: Aided read with InferRead Lung CT.AI
Radiologists read chest CT scans with the aid of InferRead Lung CT.AI
- Detection accuracy [ Time Frame: 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.
- Reading time change [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119960
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Jean Jeudy 410-328-5413 email@example.com|