Using AI to manage uncertain lung nodules
Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
This study is testing if using an AI tool to help assess uncertain lung nodules can improve how doctors manage patients and reduce unnecessary procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06638398 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a biomarker platform called the Virtual Nodule Clinic for managing indeterminate pulmonary nodules (IPNs). The study compares standard care with the addition of a radiomic prediction score to assess the likelihood of malignancy in lung nodules. Patients will be randomized into two groups: one receiving standard care alone and the other receiving standard care plus the AI-based prediction score. The goal is to determine if the radiomic score can improve patient management and reduce unnecessary procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 and older with undiagnosed indeterminate pulmonary nodules measuring 8-30mm.
Not a fit: Patients with pure ground glass nodules, known active malignancies, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate management of lung nodules, reducing unnecessary invasive procedures and improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI and biomarker platforms for similar applications, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Fabien Maldonado, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Vanderbilt-Ingram Services for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.