Deep Learning, Early Cancer Detection, Health Screening, Lung Cancer
Conditions
Keywords
Deep learning, AI, Chest x-ray
Brief summary
The goal of this clinical trial is to evaluate whether an AI tool that alerts providers to patients at high 6-year risk of lung cancer based on their chest x-ray images will improve lung cancer screening CT participation. The main question it aims to answer is: Does the AI tool improve lung cancer screening CT participation at 6 months after the baseline outpatient visit? The intervention is an alert to the provider to discuss lung cancer screening CT eligibility, for patients considered at high risk of lung cancer based on CXR-LC AI tool. Intervention and non-intervention arms will be compared to determine if lung cancer screening CT participation increases. Individuals who are considered high-risk by the tool, but who do not meet the Medicare/USPSTF pack-year or quit-date lung screening eligibility criteria may be offered research lung screening CT.
Interventions
OTHERCXR-LC
Alert to provider to discuss lung cancer screening CT eligibility, for patients considered at high risk of lung cancer based on CXR-LC AI tool.
Sponsors
Massachusetts General Hospital
Harvard Risk Management Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Scheduled outpatient appointment with participating provider. * 50- to 77-year-old who currently or formerly smoked, to include persons potentially eligible for lung screening based on Medicare guidelines. * Recent (within 2 years) PA chest radiograph.
Exclusion criteria
• History or signs/symptoms of lung cancer. Recent (within 2 years) chest CT. Clinical indication for chest CT beyond lung cancer screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion completing Lung Cancer screening CT in 6 months after visit | 6 months | To assess impact on lung cancer screening CT participation (defined as completing lung cancer screening CT) in the 6 months after the baseline visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suspicious lung nodules | 6 months | Suspicious lung nodules (Lung-RADS 4a or greater, including lung nodules ≥8 mm in diameter) identified on CT or diagnosed lung cancer. |
Countries
United States
Contacts
CONTACTMichael T Lu, MD, MPH
Outcome results
None listed