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

Recruiting now

Conditions studied: Lung Biopsy

In brief

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)

Key facts

Study ID

NCT07045103

Run by

Invenio Imaging Inc.

People needed

900

Starts

2023-12-21

Expected to finish

2026-05-01

Last updated by the study team

2025-07-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient is a prisoner.
• The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• UNC Medical Center — Chapel Hill, North Carolina, United States (enrolling)
• Corewell Health — Grand Rapids, Michigan, United States (enrolling)
• UC San Diego — San Diego, California, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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