Lung Neoplasms
Conditions
Keywords
Peripheral pulmonary nodule, Needle-based confocal laser endomicroscopy, Robotic-assisted bronchoscopy, Monarch
Brief summary
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
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.
Interventions
DEVICEnCLE aided RANB biospy
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.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Assessed by Proportion of Participants with Accurate 'Tool-in-lesion' Position During Needle-based Confocal Laser Scanning Endomicroscopy (nCLE)-Aided Robotic-Assisted Navigational Bronchoscopy (RANB) | Intra-procedure | Cone-beam computed tomography (CBCT) is used to determine the accuracy of the 'tool-in-lesion' position as obtained during nCLE-aided bronchoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the real-time nCLE imaging assessment for malignancy | Intra-procedure | The real-time nCLE imaging assessment of the index PPN for malignancy will be compared to the histopathology biopsy results of the index PPN. |
| Diagnostic yield | up to 12 months post procedure | Diagnostic yield for all nCLE aided RANB biopsy performed for the index PPN will be evaluated based on histopathological assessment of acquired tissue samples. |
| Sensitivity of the post-procedure nCLE image assessment for malignancy | Intra-procedure | 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- and inter-observer agreement of the post-procedure nCLE imaging for malignancy | Intra-procedure | 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. |
| Safety of nCLE aided RANB biopsy procedure | up to 30 days post 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. |
Countries
United States
Contacts
STUDY_DIRECTORBalaji Laxmanan, MD
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed