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Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules
NCT06638398 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- OTHER Best Practice
- OTHER Electronic Health Record Review
- DEVICE Diagnostic Procedure
Study Locations (5)
Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville
- Meharry Medical College — Nashville
- VA Tennessee Valley Healthcare Center — Nashville
Colorado
- University of Colorado — Aurora
Missouri
- Washington University in St. Louis — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-10-31 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06638398
The ClinicalTrials.gov registry entry for NCT06638398 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lung Neoplasm appearing as the primary indexed condition, and to 4 interventions — of which Computed Tomography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06638398 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Tennessee, Colorado, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06638398 about?
NCT06638398 is a clinical study titled "Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules". 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 ...
What is the current status of trial NCT06638398?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-10-31. Estimated completion is 2027-04-30.
What conditions does trial NCT06638398 study?
This clinical trial studies the following conditions: Lung Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06638398?
The interventions under investigation include: Computed Tomography (PROCEDURE), Best Practice (OTHER), Electronic Health Record Review (OTHER), Diagnostic Procedure (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06638398?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06638398 being conducted?
This trial has 5 study locations across Colorado, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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