A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Biopsy. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection
Overview
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)
Primary outcome measures
- Peripheral TBBx and CBx Co-primary Endpoints [Time frame: From enrollment to the End of the Procedure.]
- Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint [Time frame: From enrollment to the End of the Procedure.]
- Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint [Time frame: From enrollment to the End of the Procedure.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patient is a prisoner.
- The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 7 centers
- UC San Diego — San Diego
- Mayo Clinic Jacksonville — Jacksonville
- Corewell Health — Grand Rapids
- Memorial Sloan Kettering Cancer Center — New York
- Montefiore Medical Center — The Bronx
- UNC Medical Center — Chapel Hill
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT07045103 · INV-01-2022 · 1R44CA281581-01