Deep Learning Using Chest X-Rays to Identify High Risk Patients for Lung Cancer Screening CT

Massachusetts General Hospital1,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

1,500

Conditions

Lung Cancer Health Screening Early Cancer Detection Deep Learning

Eligibility

Sex: ALLMin age: 50 YearsMax age: 77 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 months

Secondary Outcomes

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.