Clinical Validation of InferRead Lung CT.AI

Lung Cancer Clinical Trial

Official title:

Clinical Validation of InferRead Lung CT.AI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119960
• Other study ID #: InferRead01
• Status: Completed
• Start date: January 10, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: July 2020
• Source: Infervision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Lung cancer screening eligible patients

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Aided read with InferRead Lung CT.AI
Radiologists read chest CT scans with the aid of InferRead Lung CT.AI

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Infervision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection accuracy	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.	20 hours
Secondary	Reading time change	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.	20 hours