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RecruitingObservational

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

NCT ID: NCT07045103Sponsor: Invenio Imaging Inc.Last updated: 2025-07-01

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)

Arms & interventions

Outcome measures

Primary

  • Peripheral TBBx and CBx Co-primary Endpoints

    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)

    Time frame: From enrollment to the End of the Procedure.

  • Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint

    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).

    Time frame: From enrollment to the End of the Procedure.

  • Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint

    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.

    Time frame: From enrollment to the End of the Procedure.

Eligibility criteria

Sex: AllAge: 22 Years and olderHealthy volunteers: No
Inclusion 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. Exclusion Criteria: 1. Patient is a prisoner. 2. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures

Study locations (7)

UC San Diego

San Diego, California, 92037

Recruiting
George Z Cheng, MD · Contact
619-543-5840gcheng@ucsd.edu
George Z Cheng, MD · Principal Investigator

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

Not Yet Recruiting
Bryan Husta, MD · Contact
(904) 953-2861Husta.Bryan@mayo.edu
Bryan Husta, MD · Principal Investigator

Corewell Health

Grand Rapids, Michigan, 49503

Recruiting
Gustavo Cumbo-Nachelli, MD · Contact
616-821-8890Gustavo.CumboNacheli@corewellhealth.org
Gustavo Cumbo-Nachelli, MD · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Suspended

Montefiore Medical Center

The Bronx, New York, 10467

Recruiting
Daniel Da Costa, MD · Contact
718-920-6441daniel.dacosta@nyulangone.org
Daniel Da Costa, MD · Principal Investigator

UNC Medical Center

Chapel Hill, North Carolina, 27514

Recruiting
Jason Akulian, MD · Contact
860-770-4835akulian@email.unc.edu
Jason Akulian, MD · Principal Investigator

MD Anderson Cancer Center

Houston, Texas, 77030

Active Not Recruiting