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

Invenio Imaging Inc.

Status: Enrolling

Conditions: Lung Biopsy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07045103

INV-01-2022

1R44CA281581-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Enrollment: 900 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

900 participants in 1 patient group

ON-SITE Patients

Description:

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.