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ACTIVE NOT RECRUITING
NCT06638398
NA

Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules

Sponsor: Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

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

PROCEDURE

Computed Tomography

Undergo standard of care Computed Tomography

DEVICE

Diagnostic Procedure

Receive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software.

OTHER

Best Practice

Receive standard of care lung nodule management

OTHER

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