The Development, Safety, and Feasibility of an Artificial Intelligence-Powered Platform (NodeAI) for Real-Time Prediction of Mediastinal Lymph Node Malignancy During Endobronchial Ultrasound Staging for Lung Cancer

Trial Title: The Development, Safety, and Feasibility of an Artificial Intelligence-Powered Platform (NodeAI) for Real-Time Prediction of Mediastinal Lymph Node Malignancy During Endobronchial Ultrasound Staging for Lung Cancer

NCT ID: NCT06540196

Condition: Lung Cancer
Non Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: NodeAI
Description: The ultrasound video and images of each LN will be analyzed by NodeAI, which will assign a CLNS for each LN based on the four ultrasonographic features of the CLNS, predict LN malignancy, and determine whether to biopsy it or not.
Arm group label: NodeAI

Intervention type: Diagnostic Test
Intervention name: Surgeon
Description: The ultrasound video and images of each LN will first be analyzed by the surgeon, who will assign a CLNS for each LN based on the four ultrasonographic features of the CLNS, predict LN malignancy, and determine whether to biopsy it or not.
Arm group label: Surgeon

Summary: Lung cancer is the leading cause of annual cancer deaths globally, more than breast, prostate, and colon cancers combined. The staging of chest lymph nodes (LNs) is a crucial step in the lung cancer diagnostic pathway because it aids in treatment decisions - whether a patient is a candidate for lung resection, chemotherapy, radiation, or multimodal treatments. Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) is the current standard for chest nodal staging for non-small cell lung cancer (NSCLC), and guidelines mandate that Systematic Sampling (SS) of at least 3 chest LN stations be routinely performed for accurate staging. Unfortunately, EBUS-TBNA yields inaccurate results in 40% of patients, leading to misinformed treatment decisions. This proportion is much higher in patients with Triple Normal LNs [LNs that appear normal on computed tomography (CT) scans, positron emission tomography (PET) scans, and EBUS], which have been found to have a > 93% chance of being truly benign. This is because EBUS-TBNA is based on ultrasound, whose success highly depends on the skill of the person performing it (operator). When the operator makes an error, the entire procedure is jeopardized. This causes downstream delays in treatment due to repeated testing and ill-informed treatment decisions. Over the past decade, the investigator has been conducting a series of research studies and trials: the development and validation of the Canada Lymph Node Score (CLNS) - a surgeon-derived semi-quantitative measure of LN malignancy; an Artificial Intelligence (AI)-based version of the CLNS to predict malignancy; and a fully autonomous AI that learned to predict malignancy directly from ultrasound images, to introduce AI to the decision-making pathway in NSCLC. This resulted in the creation of an AI-powered software to predict malignancy in mediastinal LNs of patients with lung cancer. The software is currently housed in cloud storage and its applications are latent - which means that LN images must be uploaded to the software, and results are received at a future time. In its current form, the software is not ready for clinical application due to this latency. In this project, the investigator aims to build a point-of-care device which will house the software (NodeAI) and deliver real-time results to the surgeon, and this device will be tested in a clinical trial.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients ≥ 18 years of age diagnosed with suspected or confirmed NSCLC based on CT and PET scans that are referred for chest staging by EBUS-TBNA - CT and PET scans completed Exclusion Criteria: - Patients with cN0 disease AND peripheral tumors AND tumors < 2 cm in diameter (those do not require chest staging)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 1, 2025

Completion date: December 31, 2025

Lead sponsor:
Agency: St. Joseph's Healthcare Hamilton
Agency class: Other

Source: St. Joseph's Healthcare Hamilton

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06540196