Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).

Detailed Description
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Robotic-assisted navigational bronchoscopy (RANB) improves accuracy of lesion localization and diagnostic yield of the peripheral pulmonary nodule (PPN) biopsy compared to conventional flexible bronchoscopy. Needle based confocal laser endomicroscopy (nCLE) allows real-time microstructural imaging of lung nodule tissues at the needle tip. The study is designed to evaluate the safety and feasibility of utilizing nCLE during RANB biopsy procedure to optimize needle position and diagnostic accuracy, as well as reduce or replace the need for additional imaging tools such as radial endobronchial ultrasound (r-EBUS), cone beam computed tomography (CBCT), and/or fluoroscopy during RANB biopsy.

Official Title
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Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Device: nCLE aided RANB biospy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years at signing of informed consent form (ICF). Undergoing standard-of-care RANB for a solid lung nodule, which is considered to be at intermediate- to high-risk for malignancy as determined by the investigator per the institution's standard of care. ICF signed before any study procedures are initiated. Exclusion Criteria: Medical contraindication to bronchoscopy under general anesthesia, or lack of physical fitness to undergo bronchoscopy under general anesthesia or to follow the study processes, as assessed by the investigator. Presence of uncorrectable bleeding disorders, or anticoagulation/anti-platelet aggregation therapy that cannot be withheld for an appropriate interval prior to the procedure, as defined per the institution's standard of care. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemakers. Subjects who have a target lesion that shows endobronchial involvement on chest CT. Participation in any other clinical trial within 30 days of enrollment, that would interfere with this study. Known hypersensitivity to fluorescein sodium or any other ingredients in the fluorescein product. Planned surgical resection at the time of bronchoscopy Female subjects who are pregnant or nursing at the time of the procedure.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nCLE aided RANB biopsy<br>Single arm study | Device: nCLE aided RANB biospy<br>* nCLE aided RANB biopsy procedure using the Monarch® robotic-assisted navigational bronchoscopy platform and Cellvizio® I.V.E. system with AQ-Flex™ 19 Confocal Miniprobe™ used in combination with Fluorescein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy. | The accuracy of the positional relationship between the nCLE needle/probe and the index PPN will be determined using CBCT imaging. | Intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the real-time nCLE imaging assessment for malignancy | The real-time nCLE imaging assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN. | Intra-procedure | 
| Diagnostic yield | Diagnostic yield for all nCLE aided RANB biopsy performed for the index PPN will be evaluated based on histopathological assessment of acquired tissue samples. | up to 12 months post procedure | 
| Sensitivity of the post-procedure nCLE image assessment for malignancy | The post-procedure nCLE image assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN. | Intra-procedure | 
| Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy | The post-procedure nCLE image assessment of the index PPN will be obtained by multiple independent, blinded raters; the intra- and interobserver agreement will be determined. | Intra-procedure | 
| Safety of nCLE aided RANB biopsy procedure | The safety of nCLE aided RANB biopsy procedure will be reported as the number and frequency of adverse events (AEs) and procedure-related AEs. | up to 30 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral pulmonary nodule, Needle-based confocal laser endomicroscopy, Robotic-assisted bronchoscopy, Monarch