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

NCT07045103 | Recruiting

• 2 other identifiers: INV-01-20221R44CA281581-01
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 7

Brief 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. 1.Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
2. 2.Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
3. 3.Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
4. 4.Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)

Conditions

Lung Biopsy

Outcome Measures

Primary Outcomes (3)

• 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)

  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).

  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.

  From enrollment to the End of the Procedure.

Study Arms (1)

ON-SITE Patients

Participants must fulfill all of the following criteria in order to be eligible for the study: 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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are 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. Patients who meet criteria will be enrolled consecutively from 5 different Hospitals including MD Anderson Cancer Center, University of North Carolina Medical Center, Corewell Health, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, University of San Diego, Mayo Clinic

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (7)

UC San Diego

San Diego, California, 92037, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

SUSPENDED

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

UNC Medical Center

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 1, 2025
• Study Start: December 21, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (7)