DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution

Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · May 20, 2022

Keywords

ClinConnect Summary

The DOLCE trial is studying how an artificial intelligence (AI) tool, called the Lung Cancer Prediction (LCP) solution, can help doctors make better decisions for patients with small lung nodules found during routine chest scans. These nodules can be solid or part-solid and measure between 5 and 30 millimeters. The goal is to see if using this AI tool provides better clinical outcomes and economic benefits compared to the usual care that patients currently receive.

To participate in this study, you need to be at least 35 years old and have a specific type of pulmonary nodule detected on a CT scan. However, if you have had a cancer diagnosis in the last five years, more than five nodules, or certain other conditions, you may not be eligible. If you join the study, you will be monitored to see how the AI tool influences your treatment decisions and outcomes. This trial is currently recruiting participants, and all genders are welcome to apply.

Gender

ALL

Eligibility 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