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Clinical Validation of InferRead Lung CT.AI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119960
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lung Cancer Device: Aided read with InferRead Lung CT.AI

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Lung cancer screening eligible patients
Criteria

Inclusion Criteria:

  • Lung cancer screening eligible patients

Exclusion Criteria:

-


Information from the National Library of Medicine

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


Locations
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United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jean Jeudy    410-328-5413    jjeudy@umm.edu   
Sponsors and Collaborators
Infervision

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Responsible Party: Infervision
ClinicalTrials.gov Identifier: NCT04119960    
Other Study ID Numbers: InferRead01
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes