Led by Principal Investigator Daniel J. DaCosta, MD, Montefiore Einstein is participating in the multicenter, prospective observational ON-SITE Study, which is designed to train and validate deep-learning algorithms that analyze fresh lung biopsy tissue in real time during bronchoscopy. Using the NIO® Laser Imaging System in the procedure room, the study evaluates AI-enabled identification of cell and tissue morphology suspicious for cancer in biopsies of peripheral lung nodules and mediastinal and hilar lymph nodes, without requiring traditional tissue processing such as staining or sectioning, or the physical presence of on-site cytology.

As one of only seven sites nationwide, Montefiore Einstein is shaping the way artificial intelligence may accelerate lung cancer diagnosis at the point of care. By enabling faster, real-time assessment of biopsy tissue during bronchoscopic procedures, this approach has the potential to shorten the time to diagnosis, support more informed clinical decision-making and reduce delays between biopsy and definitive care, when early, timely action matters most for patients.

The ON-SITE Study combines stimulated Raman histology with AI using the investigational NIO® Laser Imaging System developed by Invenio Imaging for rapid lung cancer detection. The system enables high-resolution digital imaging of fresh biopsy tissue directly in the procedure room during bronchoscopy, allowing AI algorithms to identify cell and tissue morphology suspicious for malignancy in near real time, while preserving samples for standard pathology and molecular testing.

Importantly, the Study evaluates this technology across multiple biopsy locations and techniques commonly used at Montefiore Einstein, including transbronchial forceps biopsy, transbronchial needle aspiration, endobronchial ultrasound-guided lymph node biopsy and transbronchial cryobiopsy. This comprehensive approach reflects Montefiore Einstein’s depth of expertise in interventional pulmonology and its commitment to rigorously evaluating new and emerging technologies before clinical adoption.

Lung cancer remains one of the leading causes of cancer-related deaths in the United States, driving widespread screening efforts for individuals at increased risk. Each year, approximately 1.6 million new pulmonary nodules are incidentally identified nationwide. While advances in bronchoscopic and biopsy techniques have expanded access to minimally invasive diagnosis, obtaining sufficient tissue for definitive diagnosis, comprehensive biomarker testing and treatment planning remains a persistent challenge.

Clinical guidelines recommend rapid on-site evaluation (ROSE) of bronchoscopic biopsy samples when available; however, ROSE requires specialized cytology personnel and may not be accessible in many procedural settings. The ON-SITE Study addresses this gap by evaluating AI-assisted tissue assessment performed directly in the bronchoscopy suite, exploring a scalable approach that could support faster diagnostic insight and broaden access to timely, high-quality lung cancer evaluation.

Montefiore Einstein’s participation in this national trial builds on its broader leadership in early lung cancer detection, advanced bronchoscopy and integrated cancer care. Through continued investment in research, technology and multidisciplinary collaboration, Montefiore Einstein is helping define how AI can enhance clinical decision-making, bringing faster answers and more precise care to patients at risk of lung cancer.

Montefiore Einstein is ranked in the top 1% of all hospitals in the nation for pulmonology and lung surgery and cancer care, according to U.S. News & World Report. Our Comprehensive Lung Program is fully integrated with Montefiore Einstein Comprehensive Cancer Center, among the elite 1% of National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S.

For information about enrolling a patient in this clinical trial, please call 718-920-6441. ClinicalTrials.gov ID: NCT07045103