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

Launched by INVENIO IMAGING INC. · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial, called the ON-SITE study, is looking at a new way to quickly detect lung cancer during lung biopsy procedures. Instead of sending tissue samples to a lab for traditional testing, this study uses a special laser imaging system combined with artificial intelligence (AI) right in the procedure room. The AI helps doctors spot signs of cancer in lung tissue or nearby lymph nodes faster than usual. This could speed up diagnosis and help guide treatment sooner.

The study is open to adults 22 years and older who are scheduled for lung biopsies because their doctor suspects they might have lung cancer. Participants will undergo one of several types of biopsies, which involve collecting small samples from lung nodules or lymph nodes using different tools. If you join, the new imaging and AI technology will be used during your routine biopsy procedure to analyze the tissue immediately, but the procedure itself will be the same as usual. This study is still recruiting participants, and it is important that you are able to safely undergo the biopsy and understand the consent form before joining. Prisoners and those deemed unsuitable by the doctor cannot participate.

Gender

ALL

Eligibility criteria

• 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