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

a study on Lung Biopsy Lung Cancer

Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around
Principal Investigator
by George Z Cheng, MD

Description

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)

Official Title

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

Keywords

Lung Biopsy

Eligibility

You can join if…

Open to people ages 22 years and up

  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.

You CAN'T join if...

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

Locations

  • UC San Diego accepting new patients
    San Diego California 92037 United States
  • MD Anderson Cancer Center in progress, not accepting new patients
    Houston Texas 77030 United States
  • Corewell Health accepting new patients
    Grand Rapids Michigan 49503 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Invenio Imaging Inc.
ID
NCT07045103
Study Type
Observational
Participants
Expecting 900 study participants
Last Updated
Contact us about this trial