Evaluating an AI tool for lung cancer prediction in patients with pulmonary nodules
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes
This study is testing whether an AI tool can help doctors better predict lung cancer in patients with certain types of lung nodules found on CT scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Locations | 10 sites (Bangor and 9 other locations) |
| Trial ID | NCT05389774 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 35 years or older with incidentally detected solid or part-solid pulmonary nodules measuring 5-30mm.
Not a fit: Patients with a cancer diagnosis in the last 5 years or those with thoracic implants affecting imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of lung cancer predictions, leading to better patient outcomes and more efficient healthcare resource utilization.
How similar studies have performed: Other studies utilizing AI for lung cancer prediction have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bangor and 9 other locations
- 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)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (Recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.