Active Not RecruitingNot applicableNCT06638398
Official study title

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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedComputed Tomography and Diagnostic Procedure

Plus 2 other study approaches.

Who it may be forLung Neoplasm

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Vanderbilt-Ingram Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Vanderbilt-Ingram Cancer Center
Interventions being studied
Procedure: Computed Tomography; Device: Diagnostic Procedure; Other: Best Practice; Other: Electronic Health Record Review
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Adults 35-year-old and older with undiagnosed IPN(s) 8-30mm referred for evaluation
  • Referral includes direct in-basket messages in the electronic healthcare record (EHR) to study providers, telehealth visits or clinic visit
  • For multiple nodules, we will obtain the score from the dominant or most suspicious nodule based on providers or radiologist impression
  • Available CT scan with slice thickness of 3 mm or less with the nodule of interest present. Nodules identified during screening low dose computed tomography of the chest (LDCT) that have had a conventional, follow-up CT performed are eligible for inclusion
Reasons someone may not be able to joinExclusion criteria
  • Pure ground glass nodule
  • Patients known to be a prisoners
  • Patients known to be pregnant
  • Known active malignancy within the last 5 years at time of enrollment (excluding non-melanoma skin cancers)
  • More than 5 IPNs present on imaging
  • Nodules referred after initial LDCT for screening with only one LDCT available. The Lung Cancer Prediction Convolutional Neural Network (LCP CNN) algorithm is not currently validated for screening studies
  • Thoracic implants that impact the image appearance of the nodule
  • Clinician determines that use of the LCP CNN model is required or contraindicated for the optimal care of the patient

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of ColoradoAurora, Colorado
  • Washington University in St. LouisSt Louis, Missouri
  • Vanderbilt University/Ingram Cancer CenterNashville, Tennessee
  • Meharry Medical CollegeNashville, Tennessee
  • VA Tennessee Valley Healthcare CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 27, 2026. Always confirm current availability with the study team.

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