Recruiting

Observational Study

Sponsor:

Invenio Imaging Inc.

Code:

NCT07045103

Conditions

Lung Biopsy

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Study Details

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. 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)

Conditions

Lung Biopsy

Study ID

NCT07045103

Start date

Dec 21, 2023

Status verified date

Jun, 2025

Completion date

May, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Peripheral TBBx and CBx Co-primary Endpoints [ Time Frame: From enrollment to the End of the Procedure. ]
  • Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint [ Time Frame: From enrollment to the End of the Procedure. ]
  • Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint [ Time Frame: From enrollment to the End of the Procedure. ]

Central Contacts and Locations

Locations

UC San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

George Z Cheng, MD

619-543-5840gcheng@ucsd.edu

Principal Investigator:

George Z Cheng, MD

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Gustavo Cumbo-Nachelli, MD

616-821-8890Gustavo.CumboNacheli@corewellhealth.org

Principal Investigator:

Gustavo Cumbo-Nachelli, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Daniel Da Costa, MD

718-920-6441daniel.dacosta@nyulangone.org

Principal Investigator:

Daniel Da Costa, MD

UNC Medical Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jason Akulian, MD

860-770-4835akulian@email.unc.edu

Principal Investigator:

Jason Akulian, MD

More Information

Sponsor

Invenio Imaging Inc.

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Invenio Imaging Inc. on 2025-07-01.