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

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.

Conditions

• Lung Neoplasm

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Fabien Maldonado, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-31

Primary Completion

2027-01-30

Completion

2027-04-30

FDA Device

Yes

Countries

• United States

Study Locations