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Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Sponsor: Abramson Cancer Center at Penn Medicine
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.
Official title: Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
Key Details
Gender
All
Age Range
35 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-01-09
Completion Date
2027-12-31
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Optellum Virtual Nodule Clinic
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)
Penn Medicine University City
Philadelphia, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Penn Medicine Washington Square
Philadelphia, Pennsylvania, United States