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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

Recruitingn/aAges 22 Years - anyAllInvenio Imaging Inc.
NCT07045103 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

7 sites
UC San Diego
San Diego, United States
Mayo Clinic Jacksonville
Jacksonville, United States
Corewell Health
Grand Rapids, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Montefiore Medical Center
The Bronx, United States
UNC Medical Center
Chapel Hill, United States
MD Anderson Cancer Center
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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