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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 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.

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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)

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

FieldValue
Enrollment Target 900 participants
Start Date 2023-12-21
Est. Completion 2026-05

Sponsor

Invenio Imaging

1 total trials

What the Registry Record Tells You About NCT07045103

The ClinicalTrials.gov registry entry for NCT07045103 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Invenio Imaging, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lung Biopsy appearing as the primary indexed condition, and to 0 interventions.

NCT07045103 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.