Lung Nodule
Conditions
Keywords
chest x-ray, CAD software
Brief summary
chest x-rays will be analyzed by AI software for a secondary read of lung nodules. Chest x-rays will either be sent to the AI tool to be read or to radiologists to read. If the image is sent to the AI tool, the AI software will generate a report on if it detects a lung nodule or not. The image will then be sent to a radiologist to determine if there is agreement or disagreement with the AI tool.
Detailed description
The study is a prospective study for measuring the performance of an AI software in detecting lung nodules from chest X-rays. Data collected during the study will be analyzed for study purposes after end date of data collection. There will be two study arms: the control arm and the interventional arm. Control Arm: There will be no interruption to the existing standard of care pathway. Interventional Arm: Use of AI will occur in parallel to the standard of care pathway. Consistent with the control Arm, the radiologists or clinicians interpreting the chest x-ray images will proceed as usual based on the existing standard operating procedures of the study site. In addition, the AI software will function as a second reader; meaning images will be processed by the AI software which will generate a report. In the event that the radiologist and the AI tool do not agree, cases will be reviewed by qualified study team members twice per week.
Interventions
DEVICEAI Based CAD Software (qXR-Ln)
All x-ray images have already been obtained and will then be run through CAD software for secondary nodule detection
Sponsors
University Hospitals Cleveland Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Chest X-ray images of patients aged 18 - 89 years. * Modality: CR/DR/DX. * PA/view * Lung nodules measuring 6 mm -30 mm (for chest X-ray images where presence of nodules is required).
Exclusion criteria
* Incomplete view of the chest. * Lateral view * Known lung cancer at the time of Chest x-ray images.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with actionable lung nodule as measured by CT scan | up to one year |
| total number of patients having chest x-ray | up to one year |
| number of patients with high risk lung nodule as measured by CT scan | up to one year |
| total number of patients referred for a CT scan | up to one year |
| number of lung nodule positive images | up to one year |
| number of lung nodule negative images | up to one year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmit Gupta, MD
University Hospitals Cleveland Medical Center
Outcome results
None listed