Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07045103 · ClinicalTrials.gov registry record
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
A clinical trial of Lung Biopsy, sponsored by Invenio Imaging.
- Recruiting
- Registry status
- 900
- Enrollment target
- 7
- Study locations
NCT07045103: Recruiting study of Lung Biopsy, sponsored by Invenio Imaging.
NCT07045103 is a study of Lung Biopsy that is actively recruiting participants, run by Invenio Imaging. The registered enrollment target is 900 participants. The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07045103, a study of Lung Biopsy, is actively recruiting participants, sponsored by Invenio Imaging.
- RECRUITING
- Registry status
- 900 participants
- Enrollment target
- 7
- Study locations
Study 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)
Primary Outcome
Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC)
Conditions Studied
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center - The Bronx
California
- UC San Diego - San Diego
Florida
- Mayo Clinic Jacksonville - Jacksonville
Michigan
- Corewell Health - Grand Rapids
North Carolina
- UNC Medical Center - Chapel Hill
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2026-05 |
What NCT07045103 shows while recruiting
NCT07045103 is an observational study that tracks outcomes without assigning an intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Lung Biopsy appearing as the primary indexed condition, and to 0 interventions.
NCT07045103 lists 7 locations in 6 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT07045103 about?
NCT07045103 is a clinical study titled "A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study". 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 N...
What is the current status of trial NCT07045103?
This trial is currently recruiting. The enrollment target is 900 participants. The study started on 2023-12-21. Estimated completion is 2026-05.
What conditions does trial NCT07045103 study?
This clinical trial studies the following conditions: Lung Biopsy.
Who is sponsoring clinical trial NCT07045103?
This trial is sponsored by Invenio Imaging, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07045103 being conducted?
This trial has 7 study locations across California, Florida, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02352116 · 900 participants · NA
Evaluation of Post-PACU Pain Management in Pediatric Surgery
- NCT02414347 · 900 participants
F 18 T807 Tau PET Imaging of Alzheimer's Disease
- NCT02670408 · 900 participants
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
- NCT02960022 · 900 participants · Phase 2
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI