Radiomics Tool for Pulmonary Nodule Risk Stratification
Lung Cancer, Pulmonary Nodule, Solitary
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring clinical effectiveness, clinical utility, artificial intelligence, medical decision-making, risk stratification
Eligibility Criteria
Inclusion Criteria: Male or female, aged 35-89 years Scheduled to be evaluated at a pulmonary nodule clinic Newly discovered solid PN 8-30mm in maximal diameter on CT imaging Chest CT imaging compatible with Optellum Virtual Nodule Clinic software and available on or before the date of index clinic visit Exclusion Criteria: Chest CT imaging with mediastinal or hilar lymphadenopathy by CT size criteria (>10mm in maximal short-axis diameter on axial CT images) PNs with popcorn calcification (consistent with benign etiology) Subsolid PNs (may be associated with lower risk of clinically significant malignancy) Known history of active cancer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Usual care (clinician assessment)
Clinician assessment + CAD-based risk stratification
In the usual care arm, clinicians will evaluate individuals with indeterminate pulmonary nodules as part of routine clinical care. No specific guidance regarding pulmonary nodule risk stratification will provided to evaluating clinicians.
In the experimental arm, evaluating clinicians will receive an electronic health record-based alert with the report from an artificial intelligence radiomics-based computer-aided diagnosis tool for risk stratification of pulmonary nodules.