RecruitingNot ApplicableNCT05968898

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

300 participants

Start Date

Jan 9, 2024

Study Type

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

Min Age: 35 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a computer-assisted tool that uses radiomics (mathematical analysis of CT scan images) to help doctors assess whether a lung nodule is likely to be cancerous. Lung nodules are small spots found on CT scans that need follow-up to determine if they are benign or malignant. The tool being tested is called the Optellum Virtual Nodule Clinic. The goal is to see if this AI-assisted approach improves the accuracy and efficiency of lung nodule assessment. **You may be eligible if...** - You are between 35 and 89 years old - You have a newly discovered lung nodule (solid or part-solid) measuring 8–30mm found on a CT scan within the last 60 days - You are scheduled to be seen at a pulmonary nodule clinic - Your CT scan meets the technical requirements for the software **You may NOT be eligible if...** - You have significantly enlarged lymph nodes in the chest on CT scan - Your nodule has a popcorn-type calcification (typically a benign pattern) - Your nodule is pure ground-glass (a lower-risk type) - Your nodule was seen on a scan more than 60 days before your most recent CT - You have more than one suspicious nodule in the 8–30mm range - You have a history of lung cancer or another active cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOptellum 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

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NCT05968898


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