NCT06638398

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To test the hypothesis that usual care plus a radiomic prediction score impacts patient management compared to usual care alone. II. To conduct a multicenter pragmatic randomized controlled platform trial using a validated biomarker, the radiomic prediction score. III. To conduct a biomarker study that will evaluate the first necessary (but not sufficient) step to show clinical utility. IV. To assess the magnitude of change in patient management with use of the radiomic prediction score. V. To develop a platform that can be used as framework for future larger biomarker studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard of care (SOC) computed tomography (CT) evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study. ARM II: Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.

Conditions

• Lung Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo standard of care Computed Tomography
DEVICE	Diagnostic Procedure	Receive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software.
OTHER	Best Practice	Receive standard of care lung nodule management
OTHER	Electronic Health Record Review	Ancillary Studies

Timeline

• Start date: 2024-10-31
• Primary completion: 2027-01-30
• Completion: 2027-04-30
• First posted: 2024-10-15
• Last updated: 2026-03-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study