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

Last updated: June 20, 2025
Sponsor: Invenio Imaging Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT07045103
INV-01-2022
1R44CA281581-01
  • Ages > 22
  • All Genders

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient or legal guardian is willing and able to understand, sign and date theEthics 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) withan intermediate to high pretest probability of lung cancer based on cliniciansuspicion.

  4. The patient can tolerate the clinical procedure as indicated.

Exclusion

Exclusion Criteria:

  1. Patient is a prisoner.

  2. The participant, in the judgment of the Investigator, may be inappropriate for theintended study procedures

Study Design

Total Participants: 900
Study Start date:
December 21, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • UC San Diego

    San Diego, California 92037
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Suspended

  • UNC Medical Center

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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