Status:
RECRUITING
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Lead Sponsor:
Invenio Imaging Inc.
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
University of North Carolina, Chapel Hill
Conditions:
Lung Biopsy
Eligibility:
All Genders
22+ years
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 canc...
Eligibility Criteria
Inclusion Criteria:
- 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 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.
- The patient can tolerate the clinical procedure as indicated.
Exclusion Criteria:
- Patient is a prisoner.
- The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
Key Trial Info
Start Date :
December 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07045103
Start Date
December 21 2023
End Date
May 1 2026
Last Update
July 1 2025
Active Locations (7)
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1
UC San Diego
San Diego, California, United States, 92037
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
3
Corewell Health
Grand Rapids, Michigan, United States, 49503
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065