Real-world performance test of an AI tool for detecting lung nodules on chest x-rays
Performance Estimation of Triaging Artificial Intelligence Based Computer-Aided Detection Algorithm in Routine Chest Radiography
This project will try an AI tool as a second reader to see if it can find lung nodules on chest x-rays from adults aged 18–89.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45991 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06597968 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study comparing chest x-ray reads with and without an AI-based CAD tool (qXR-Ln) used as a second reader alongside standard of care. Chest x-rays will be routed either through the AI tool or through usual radiologist workflow, and images processed by the AI will also be reviewed by radiologists to record agreement or disagreement. Discordant cases between AI and radiologist reads will be reviewed by qualified study team members twice weekly. Collected data will be analyzed after completion of data collection to measure the AI tool's real-world detection performance for lung nodules.
Who should consider this trial
Good fit: Adults aged 18–89 who have PA chest x-rays taken with CR/DR/DX modalities, including images showing lung nodules sized 6–30 mm when nodules are required for inclusion.
Not a fit: Patients with incomplete chest views, lateral-only images, known lung cancer at the time of imaging, or those outside the 18–89 age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the AI second read could help detect lung nodules earlier or more consistently, potentially improving follow-up and outcomes.
How similar studies have performed: Other AI-based CAD tools for chest x-ray nodule detection have shown promising results in controlled settings but real-world performance has varied and needs further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- University Hospitals — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Amit Gupta, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Lauren Hahn
- Email: Lauren.hahn@uhhospitals.org
- Phone: 216-844-9312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.