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NCT06638398 · ClinicalTrials.gov registry record · NA

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

A NA study of Lung Neoplasm, sponsored by Vanderbilt-Ingram Cancer Center.

Active
Registry status
NA
Development phase
400
Enrollment target
5
Study locations

NCT06638398: Active NA study of Lung Neoplasm, sponsored by Vanderbilt-Ingram Cancer Center.

NCT06638398 is a NA study of Lung Neoplasm that is active but no longer recruiting, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 400 participants, below the 505-participant average among 8 other Lung Neoplasm trials with a reported enrollment target (21% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06638398, a NA study of Lung Neoplasm, is active but no longer recruiting, sponsored by Vanderbilt-Ingram Cancer Center.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
5
Study locations

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.

Primary Outcome

Will be defined as referral for imaging surveillance for ultimately benign nodules, and biopsy, positron emission tomography scan, surgery or empiric stereotactic body radiation therapy for malignant nodules. Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Will compare the proportion with appropr

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

FieldValue
Enrollment Target 400 participants
Start Date 2024-10-31
Est. Completion 2027-04-30
Phase NA
Vanderbilt-Ingram Cancer Center

189 total trials

What the registry record for NCT06638398 still lists

NCT06638398 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 505-participant average among 8 other Lung Neoplasm trials with a reported enrollment target (21% lower).

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.

NCT06638398 lists 5 locations in 3 states (Tennessee, Colorado, Missouri).

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.

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).

Who is sponsoring clinical trial NCT06638398?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Lung Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06638398's enrollment target sits among peer trials

400 3rd of 8 higher than 6 of 8 other Lung Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lung Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06638398, the US trial registry maintained by the National Library of Medicine. NCT06638398 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.