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A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
NCT07045103 · Invenio Imaging Inc.
In plain English
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Official title
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection
About this study
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)
Eligibility criteria
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 target: 900 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-12-21
Estimated completion: 2026-05
Last updated: 2025-07-01
Primary outcomes
- • Peripheral TBBx and CBx Co-primary Endpoints (From enrollment to the End of the Procedure.)
- • Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint (From enrollment to the End of the Procedure.)
- • Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint (From enrollment to the End of the Procedure.)
Sponsor
Invenio Imaging Inc. · industry
With: Memorial Sloan Kettering Cancer Center, University of North Carolina, Chapel Hill, M.D. Anderson Cancer Center, Mayo Clinic, University of California, San Diego, Montefiore Medical Center-Moses-Weiler, Corewell Health
All locations (7)
UC San DiegoRecruiting
San Diego, California, United States
Mayo Clinic JacksonvilleNot Yet Recruiting
Jacksonville, Florida, United States
Corewell HealthRecruiting
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer CenterSuspended
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
UNC Medical CenterRecruiting
Chapel Hill, North Carolina, United States
MD Anderson Cancer CenterActive Not Recruiting
Houston, Texas, United States