NCT07045103 A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
| NCT ID | NCT07045103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Invenio Imaging Inc. |
| Condition | Lung Biopsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2023-12-21 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2023-12-21 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
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
Frequently Asked Questions
Who can join the NCT07045103 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Lung Biopsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07045103 currently recruiting?
Yes, NCT07045103 is actively recruiting participants. Visit ClinicalTrials.gov or contact Invenio Imaging Inc. to inquire about joining.
Where is the NCT07045103 trial being conducted?
This trial is being conducted at San Diego, United States, Jacksonville, United States, Grand Rapids, United States, New York, United States and 3 additional locations.
Who is sponsoring the NCT07045103 clinical trial?
NCT07045103 is sponsored by Invenio Imaging Inc.. The trial plans to enroll 900 participants.