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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
53
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.
John Muir Health
Concord, California, United States
Clinical Research Associates of Central PA
Altoona, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center of the American Oncologic Hospital, Inc.
Philadelphia, Pennsylvania, United States
'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.
Time frame: Intra-procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 30 days post procedure
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