RecruitingNCT05389774

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

DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes

Sponsor

Nottingham University Hospitals NHS Trust

Enrollment

2,000 participants

Start Date

Mar 23, 2023

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Pulmonary Nodule, Solitary AI (Artificial Intelligence)Pulmonary Nodule, Multiple

Summary

This study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on CT chest scans performed as part of routine practice. The aim is to determine whether physician decision making with the AI-based LCP tool, generates clinical and health-economic benefits over the current standard of care of these patients.

Eligibility

Min Age: 35 Years

Inclusion Criteria8

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 Criteria8

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