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

Invenio Imaging Inc.900 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

900

Conditions

Lung Biopsy

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (7)

UC San Diego

San Diego, California, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

NOT_YET_RECRUITING

Corewell Health

Grand Rapids, Michigan, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

SUSPENDED

Montefiore Medical Center

The Bronx, New York, United States

RECRUITING

UNC Medical Center

Chapel Hill, North Carolina, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: 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.

Time frame: From enrollment to the End of the Procedure.