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)

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Key information

Conditions

Lung Biopsy

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
The patient is 22 years of age or older.
The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.
The patient can tolerate the clinical procedure as indicated.

Exclusion criteria

Patient is a prisoner.
The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures

Treatment and study plan

Primary outcomes

Peripheral TBBx and CBx Co-primary Endpoints

Time frame: From 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 Endpoint

Time frame: From 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 Endpoint

Time frame: From 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.

Sponsors and collaborators

Lead sponsor

Invenio Imaging Inc.

Industry

Collaborators

Corewell Health
M.D. Anderson Cancer Center
Mayo Clinic
Memorial Sloan Kettering Cancer Center
Montefiore Medical Center-Moses-Weiler
University of California, San Diego
University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: ON-SITE

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jul 1, 2025
Registry last updated: Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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