NCT06638398Active, not recruiting
Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules
Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 400 (actual)
- First submitted
- 9 Oct 2024
- Start date
- 31 Oct 2024
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT06638398
What you commit to
- Study type: Interventional
- Participants enrolled: 400
- From 31 Oct 2024 to the primary completion date, 30 Jan 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Thoracic implants that impact the image appearance of the nodule
Other illness
- Known active malignancy within the last 5 years at time of enrollment (excluding non-melanoma skin cancers)
- 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
Other
- Pure ground glass nodule
- Patients known to be a prisoners
- Patients known to be pregnant
- More than 5 IPNs present on imaging
- Clinician determines that use of the LCP CNN model is required or contraindicated for the optimal care of the patient
Who the study is looking for
- 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
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| VA Tennessee Valley Healthcare Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Meharry Medical College Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.