- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119960
Clinical Validation of InferRead Lung CT.AI
July 27, 2020 updated by: Infervision
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Lung cancer screening eligible patients
Description
Inclusion Criteria:
- Lung cancer screening eligible patients
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2019
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (Actual)
October 9, 2019
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- InferRead01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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