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RecruitingNot applicableNCT07045103
Official study title

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

Study summary

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 things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forLung Biopsy

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 1, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Invenio Imaging Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Invenio Imaging Inc.
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form. 2. The patient is 22 years of age or older. 3. 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. 4. The patient can tolerate the clinical procedure as indicated.

Reasons someone may not be able to joinExclusion criteria

1. Patient is a prisoner. 2. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UC San DiegoSan Diego, California
  • Mayo Clinic JacksonvilleJacksonville, Florida
  • Corewell HealthGrand Rapids, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Montefiore Medical CenterThe Bronx, New York
  • UNC Medical CenterChapel Hill, North Carolina
  • MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2025. Always confirm current availability with the study team.

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