Evaluating an AI tool for lung cancer prediction in patients with pulmonary nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to recruit patients aged 35 and older who have solid or part-solid pulmonary nodules detected on CT scans. The focus is on assessing whether the use of an AI-based lung cancer prediction tool improves clinical decision-making and health-economic outcomes compared to the current standard of care. Patients with nodules measuring between 5-30mm will be included, and the study will take place across multiple centers. The goal is to gather data on the effectiveness of this AI solution in managing lung cancer risks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients are eligible for the study if all of the following apply:

* Are aged 35 years or above
* Have baseline CT study with at least one incidentally detected solid or part-solid (must have a solid component \>=80%) pulmonary nodule that:

  * is not fully calcified
  * Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers
* Have baseline CT study that includes at least one series that meets all of the following (training for this will be provided):

  * Is of a type that meets VNC instructions for use
  * Comprises at least one full-inspiration breath-hold scans without a high degree of contrast media and does not exhibit quality issues (e.g., motion artefacts)

Exclusion Criteria:

Patients will be excluded from the study if any of the following apply:

* Have received a diagnosis for cancer in the last 5 years
* Have thoracic implants that impact the image appearance of the nodule
* Have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis)
* Have one or more additional nodules where any of the following applies:

  * Are already undergoing follow-up according to pulmonary nodule management standard care
  * Pure ground glass opacity (GGO) of \>=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
  * \>30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers

Where it's running

• Betsi Cadwaladr University Health Board
  Bangor, United Kingdom Recruiting
• Frimley Health NHS Foundation Trust (Wexham Park Hospital)
  Frimley, United Kingdom Recruiting
• Leeds Teaching Hospitals NHS Trust
  Leeds, United Kingdom Recruiting
• King's College Hospital NHS Foundation Trust
  London, United Kingdom Recruiting
• Royal Free Hospital
  London, United Kingdom Recruiting
• St. George's University Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.