Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules
Public ClinicalTrials.gov record NCT06638398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06638398
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- Computed Tomography Procedure
- Diagnostic Procedure Device
- Best Practice Other
- Electronic Health Record Review Other
Procedure · Device · Other
Eligibility (public fields only)
- Age range
- 35 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 30, 2024
- Primary completion
- Jan 29, 2027
- Completion
- Apr 29, 2027
- Last update posted
- Mar 26, 2026
2024 – 2027
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37203 | — |
| Meharry Medical College | Nashville | Tennessee | 37208 | — |
| VA Tennessee Valley Healthcare Center | Nashville | Tennessee | 37212 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06638398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2026 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06638398 live on ClinicalTrials.gov.