Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Tennessee
Meharry Medical College
RECRUITING
Nashville
VA Tennessee Valley Healthcare Center
RECRUITING
Nashville
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Contact Information
Primary
Vanderbilt-Ingram Services for Timely Access
cip@vumc.org
800-811-8480
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 400
Treatments
Experimental: Arm I (Radiomic Prediction Score)
Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
Active_comparator: Arm II (Usual Care)
Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov