Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
Trial ID: NCT06638398
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-10-31
Completion date: 2027-04-30
Sponsor: Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions: Lung Neoplasm
Interventions: Computed Tomography; Diagnostic Procedure; Best Practice; Electronic Health Record Review
Locations: University of Colorado; Washington University in St. Louis; Vanderbilt University/Ingram Cancer Center; Meharry Medical College; VA Tennessee Valley Healthcare Center
Countries: United States; United States; United States; United States; United States
Enrollment: 400
Age range: 35 Years - None
Sex: ALL

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 criteria:
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

Outcomes:
Appropriate nodule management