Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules

Launched by VANDERBILT-INGRAM CANCER CENTER · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called the Virtual Nodule Clinic, which uses advanced technology to help doctors better manage lung nodules that aren't clearly benign (non-cancerous) or malignant (cancerous). These uncertain nodules, known as indeterminate pulmonary nodules (IPNs), can create challenges in deciding the best course of action. The Virtual Nodule Clinic uses artificial intelligence (AI) to analyze images and predict the likelihood that a nodule is cancerous, helping to avoid unnecessary procedures or delays in treatment.

To participate in the trial, you need to be an adult aged 35 or older with one or more undiagnosed lung nodules that are between 8 and 30 mm in size. You should have had a recent CT scan showing these nodules and be referred for evaluation by healthcare providers. If you join the trial, you can expect to have your nodules evaluated with this new AI technology, which may improve how your healthcare team manages your condition. It’s important to note that certain individuals, such as those with specific types of nodules or active cancers, may not be eligible for this study.

Gender

ALL

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