Using AI to manage uncertain lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.