Deep Learning Using Chest X-Rays to Identify High Risk Patients for Lung Cancer Screening CT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-77
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
CXR-LC
Other interventionAlert to provider to discuss lung cancer screening CT eligibility, for patients considered at high risk of lung cancer based on CXR-LC AI tool.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Non-InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion completing Lung Cancer screening CT in 6 months after visit
To assess impact on lung cancer screening CT participation (defined as completing lung cancer screening CT) in the 6 months after the baseline visit.
Time frame
6 monthsSecondary outcomes
1
Suspicious lung nodules
Suspicious lung nodules (Lung-RADS 4a or greater, including lung nodules ≥8 mm in diameter) identified on CT or diagnosed lung cancer.
Time frame
6 monthsSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Harvard Risk Management Foundation
Collaborator
Source ClinicalTrials.gov