A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial I
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 Sys
| Condition(s) | Lung Biopsy |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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/ |
| Who can participate | 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 |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Invenio Imaging Inc. |
| Locations | San Diego, California, United States; Jacksonville, Florida, United States; Grand Rapids, Michigan, United States; New York, New York, United States; The Bronx, New York, United States; Chapel Hill, North Carolina, United States (+1 more sites) |
| Start date | 2023-12-21 |
| NCT ID | NCT07045103 |
| Official listing | https://clinicaltrials.gov/study/NCT07045103 |