RecruitingNCT07045103

A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study

A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection


Sponsor

Invenio Imaging Inc.

Enrollment

900 participants

Start Date

Dec 21, 2023

Study Type

OBSERVATIONAL

Conditions

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 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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new technology that combines stimulated Raman histology (a special high-speed imaging technique) with artificial intelligence to get rapid, same-day results during a lung bronchoscopy procedure — potentially telling doctors right away if a lung lesion is cancerous, without waiting days for lab results. **You may be eligible if...** - You are undergoing a bronchoscopy (a procedure where a camera is passed into the airways) for suspected lung cancer - You have a lung lesion that needs evaluation - You are 18 or older and able to provide consent **You may NOT be eligible if...** - You cannot safely undergo bronchoscopy - You have conditions that prevent tissue sampling - You are pregnant or have other serious medical conditions that make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT07045103


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