RecruitingNot ApplicableNCT06638398

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

Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

400 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study (Virtual Nodule Clinic) uses an AI-based tool and blood biomarkers to help doctors better predict whether a lung nodule (a small spot found on a CT scan) is likely to be cancer or not. The goal is to reduce unnecessary follow-up scans and biopsies for low-risk nodules. **You may be eligible if...** - You are 35 or older with one or more undiagnosed lung nodules measuring 8–30 mm - You have an available CT scan with 3 mm or thinner slices - Your nodule was found incidentally or during a screening CT **You may NOT be eligible if...** - Your nodule is a pure ground glass opacity (a specific type that cannot be analyzed by the tool) - You have more than 5 lung nodules - You have a known active cancer in the past 5 years (excluding non-melanoma skin cancer) - You are pregnant - You are a prisoner 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

PROCEDUREComputed Tomography

Undergo standard of care Computed Tomography

DEVICEDiagnostic Procedure

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

OTHERBest Practice

Receive standard of care lung nodule management

OTHERElectronic Health Record Review

Ancillary Studies


Locations(5)

Washington University in St. Louis

St Louis, Missouri, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

University of Colorado

Aurora, Colorado, United States

Meharry Medical College

Nashville, Tennessee, United States

VA Tennessee Valley Healthcare Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06638398


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