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RECRUITING
NCT05968898
NA

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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

Interventions

DEVICE

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