NCT07045103Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 20 Jun 2025
- Start date
- 21 Dec 2023
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Invenio Imaging Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07045103
What you commit to
- Study type: Observational
- Planned participants: 900
- From 21 Dec 2023 to the primary completion date, 30 Apr 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient is a prisoner.
- The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
Who the study is looking for
- 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.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Corewell Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Suspended |
| UC San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.