A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study

The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing. The study includes four arms based on biopsy location and biopsy modality/tool: 1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx) 2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA) 3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA) 4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)

NCT Number	NCT07045103
Lead Sponsor	Invenio Imaging Inc. Collaborators: Memorial Sloan Kettering Cancer Center, University of North Carolina, Chapel Hill, M.D. Anderson Cancer Center, Mayo Clinic, University of California, San Diego, Montefiore Medical Center-Moses-Weiler, Corewell Health
Conditions	Lung Biopsy
Enrollment	900 participants
Start Date	2023-12-21
Primary Completion	2026-04 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2025-07-01