ON-SITE Study: Rapid Lung Cancer Detection with AI and Stimulated Raman Histology

The ON-SITE study is looking at a new way to quickly detect lung cancer during a bronchoscopy (a procedure where a doctor looks into your airways). This study uses a special imaging system called NIO Laser Imaging System with artificial intelligence (AI) to look at biopsy samples right away, without needing traditional lab processing. The goal is to train and test these AI tools to see if they can accurately find signs of cancer in samples from lung nodules and lymph nodes. You may be able to join if you are 22 or older and are already scheduled for a lung biopsy and/or lymph node staging procedure. The study aims to enroll 900 participants.

Study design
This is an observational study, meaning researchers will observe and collect information without giving you a specific treatment. It plans to include 900 participants.
What's involved
Your participation will involve having biopsy samples taken during your already scheduled lung biopsy and/or lymph node staging procedure. The study will collect data from enrollment until the end of your procedure.
Compensation
Not stated in the trial record.
Follow-up
Data collection will occur from enrollment until the end of the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07045103

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

Recruiting
Not specifiedAges 22+Observational
Invenio Imaging Inc.
~900 participants
Updated 2025-07-01 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peripheral TBBx and CBx Co-primary Endpoints
Measured over From enrollment to the End of the Procedure.
+2 more outcomes measured
Lung Biopsy
7 sites across 6 states
New York2
California1
Florida1
Michigan1
North Carolina1
Texas1

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  • Peripheral TBBx and CBx Co-primary EndpointsFrom enrollment to the End of the Procedure.

    Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC)

  • Peripheral Lung Transbronchial Fine Needle Aspiration EndpointFrom enrollment to the End of the Procedure.

    Detection of lung cancer in peripheral lung transbronchial needle aspiration by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation (ROSE).

  • Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration EndpointFrom enrollment to the End of the Procedure.

    Determine area-under-the-curve (AUC) of the receiver-operating-characteristic (ROC) of NIO image analysis module for detection of cancer at a lymph-node location.