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)
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.
Patient is a prisoner.
The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
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
Case-only
Prospective
Not listed
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)
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).
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.
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Invenio Imaging Inc.
Lead sponsor
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
