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Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules
Sponsor: Vanderbilt-Ingram Cancer Center
Summary
This clinical trial studies whether a biomarker platform, the Virtual Nodule Clinic, can be used for the management of lung (pulmonary) nodules that are not clearly non-cancerous (benign) or clearly cancerous (malignant) (indeterminate pulmonary nodules \[IPNs\]). The management of IPNs is based on estimating the likelihood that the observed nodule is malignant. Many things, such as age, smoking history, and current symptoms, are considered when making a prediction of the likelihood of malignancy. Radiographic imaging characteristics are also considered. Lung nodule management for IPNs can result in unnecessary invasive procedures for nodules that are ultimately determined to be benign, or potential delays in treatment when results of tests cannot be determined or are falsely negative. The Virtual Nodule Clinic is an artificial intelligence (AI) based imaging software within the electronic health record which makes certain that identified pulmonary nodules are screened by clinicians with expertise in nodule management. The Virtual Nodule Clinic also features an AI based radiomic prediction score which designates the likelihood that a pulmonary nodule is malignant. This may improve the ability to manage IPNs and lower unnecessary invasive procedures or treatment delays. Using the Virtual Nodule Clinic may work better for the management of IPNs.
Official title: Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-10-31
Completion Date
2027-04-30
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Computed Tomography
Undergo standard of care Computed Tomography
Diagnostic Procedure
Receive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software.
Best Practice
Receive standard of care lung nodule management
Electronic Health Record Review
Ancillary Studies
Locations (5)
University of Colorado
Aurora, Colorado, United States
Washington University in St. Louis
St Louis, Missouri, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, United States