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AI could help avoid unnecessary lung procedures

NCT ID NCT06638398

Diagnosis Sponsor: Vanderbilt-Ingram Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether an artificial intelligence (AI) tool called the Virtual Nodule Clinic can help doctors better manage lung nodules that are not clearly cancerous or benign. The AI analyzes CT scans and patient information to estimate the risk of cancer. The goal is to see if using this tool leads to more appropriate care—like monitoring harmless nodules instead of doing invasive tests, and catching cancer earlier. About 400 adults aged 35 and older with lung nodules are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

400 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion 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

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Conditions

The condition(s) this trial relates to.

lung neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung neoplasm

Contacts and locations

Locations

  • Meharry Medical College

    Nashville, Tennessee, 37208, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • VA Tennessee Valley Healthcare Center

    Nashville, Tennessee, 37212, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37203, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

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