An observational study in Lung Nodule, sponsored by University Hospitals Cleveland Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University Hospitals Cleveland Medical Center · Observational
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.
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.
University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Chest x-rays collected on patients aged 18-89
Exclusion Criteria:
these are the images going through the AI tool
Device: AI Based CAD Software (qXR-Ln)
these are the images not going through the AI tool
All x-ray images have already been obtained and will then be run through CAD software for secondary nodule detection
number of patients with actionable lung nodule as measured by CT scan
Time frame: up to one year
total number of patients having chest x-ray
Time frame: up to one year
number of patients with high risk lung nodule as measured by CT scan
Time frame: up to one year
total number of patients referred for a CT scan
Time frame: up to one year
number of lung nodule positive images
Time frame: up to one year
number of lung nodule negative images
Time frame: up to one year
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center