Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
Abramson Cancer Center at Penn Medicine
300 participants
Jan 9, 2024
INTERVENTIONAL
Conditions
Summary
This is a pragmatic clinical trial that will study the effect of a radiomics-based computer-aided diagnosis (CAD) tool on clinicians' management of pulmonary nodules (PNs) compared to usual care. Adults aged 35-89 years with 8-30mm PNs evaluated at Penn Medicine PN clinics will undergo 1:1 randomization to one of two groups, defined by the PN malignancy risk stratification strategy used by evaluating clinicians: 1) usual care or 2) usual care + use of a radiomics-based CAD tool.
Eligibility
Plain Language Summary
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Interventions
The Optellum Virtual Nodule Clinic is an FDA-approved (Class II) device for risk stratification of pulmonary nodules. It uses a convolutional neural network to evaluate CT imaging data to provide an estimate of malignancy risk for indeterminate pulmonary nodules.
Locations(3)
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NCT05968898