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NCT Number: NCT06910956

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

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.

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Key information

Conditions

Lung Cancer Deep Learning Early Cancer Detection Health Screening Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Michael T Lu, MD, MPH

CONTACT

[email protected]

617-724-9729

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CXR-LC

Other

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.

Primary outcomes

  1. Proportion completing Lung Cancer screening CT in 6 months after visit

    Time frame: 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 outcomes

  1. Suspicious lung nodules

    Time frame: 6 months

    Suspicious lung nodules (Lung-RADS 4a or greater, including lung nodules ≥8 mm in diameter) identified on CT or diagnosed lung cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael T Lu, MD, MPH

CONTACT

[email protected]

617-726-1255

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Harvard Risk Management Foundation

Registry information

Official study title

Deep Learning Using Routine Chest X-Rays and Electronic Medical Record Data to Identify High Risk Patients for Lung Cancer Screening CT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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