Actively Recruiting
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Led by Invenio Imaging Inc. · Updated on 2025-07-01
900
Participants Needed
7
Research Sites
123 weeks
Total Duration
On this page
Sponsors
I
Invenio Imaging Inc.
Lead Sponsor
M
Memorial Sloan Kettering Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is 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)
CONDITIONS
Official Title
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 mediastinal staging (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high suspicion of lung cancer.
- The patient can tolerate the clinical procedure as indicated.
You will not qualify if you...
- Patient is a prisoner.
- The participant may be inappropriate for the intended study procedures in the judgment of the Investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
UC San Diego
San Diego, California, United States, 92037
Actively Recruiting
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
3
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Suspended
5
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
6
UNC Medical Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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