A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
NCT ID: NCT07045103
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
900 participants
OBSERVATIONAL
2023-12-21
2026-05-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ON-SITE Patients
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
22 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
University of North Carolina, Chapel Hill
OTHER
The University of Texas MD Anderson Cancer Center
UNKNOWN
Mayo Clinic
OTHER
University of California, San Diego
OTHER
Montefiore Medical Center-Moses-Weiler
UNKNOWN
Corewell Health
UNKNOWN
Invenio Imaging Inc.
INDUSTRY
Responsible Party
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Locations
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UC San Diego
San Diego, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Corewell Health
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Medical Center
Chapel Hill, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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INV-01-2022
Identifier Type: -
Identifier Source: org_study_id
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