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.
Are aged 35 years or above
is not fully calcified
Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers
Is of a type that meets VNC instructions for use
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)
Are already undergoing follow-up according to pulmonary nodule management standard care
The CT scans of patients for whom a pulmonary nodule has been identified will be reviewed for study eligibility by a member of the local site's clinical team for the patient.
Cohort
Prospective
Not listed
Determine the potential effect of the LCP on discharge
Measured difference between standard care, LCP and LCP-guided care for: * Percentage of cancer patients discharged (straight after assessment of the baseline scan) * Percentage of benign-nodule patients discharged (straight after assessment of the baseline scan)
Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.
Percentage of cancer patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (correctly by more aggressive management and incorrectly for less aggressive management). Percentage of benign-nodule patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (incorrectly by more aggressive management and correctly for less aggressive management). Measured difference between standard care, LCP and LCP-guided care for: * Percentage of CT scans and PET/CT scans performed on benign-nodule patients * Percentage of non-surgical biopsies performed on benign-nodule patients * Percentage of surgical excisions on benign-nodule patients
Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.
Measured difference between standard care, LCP and LCP-guided care for: * Percentage of thoracic, respiratory or vascular events related to biopsies or surgical excisions for lung nodules or suspected lung cancer occurring within 30 days of the procedure on benign-nodule patients * Percentage of lung cancers stratified by stage * Time in days between nodule detection and lung cancer diagnosis
Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care
Measured difference between standard care, LCP and LCP-guided care for: * The composite standardized GBP costs of all healthcare-related activity for lung nodules or suspected lung cancer * Health-related utilities (life years and QALYs)
Determine the potential effect of the LCP on possible adherence to clinical guidelines.
Measured difference between standard care and LCP-guided care for : Number and percentage of patients for whom a validated risk model (Brock or LCP) is used to guide the next clinical management step (i.e., counting the instances where Brock is not used, or where LCP is not possible to compute or it is ignored).
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Nottingham University Hospitals NHS Trust
Lead sponsor
Optellum Ltd.
Collaborator
