Lung Biopsy
Conditions
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)
Interventions
None listed
Sponsors
Memorial Sloan Kettering Cancer Center
University of North Carolina, Chapel Hill
The University of Texas MD Anderson Cancer Center
Mayo Clinic
University of California, San Diego
Montefiore Medical Center-Moses-Weiler
Corewell Health
Invenio Imaging Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral TBBx and CBx Co-primary Endpoints | From enrollment to the End of the Procedure. | 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 | From enrollment to the End of the Procedure. | 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 | From enrollment to the End of the Procedure. | 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. |
Countries
United States
Outcome results
None listed