Clinical trial NCT05231278: Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
Official title: Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: Peripheral pulmonary nodule
Needle-based confocal laser endomicroscopy
Robotic-assisted bronchoscopy
Monarch
Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 53
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy.
timeFrame: Intra-procedure
Secondary outcomes:
measure: Sensitivity of the real-time nCLE imaging assessment for malignancy
timeFrame: Intra-procedure
measure: Diagnostic yield
timeFrame: up to 12 months post procedure
measure: Sensitivity of the post-procedure nCLE image assessment for malignancy
timeFrame: Intra-procedure
measure: Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy
timeFrame: Intra-procedure
measure: Safety of nCLE aided RANB biopsy procedure
timeFrame: up to 30 days post procedure
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Health
state: California
city: Altoona
country: United States
facility: Clinical Research Associates of Central PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center of the American Oncologic Hospital, Inc.
state: Pennsylvania
Study officials:
affiliation: Johnson & Johnson Enterprise Innovation Inc.
name: Balaji Laxmanan, MD
role: STUDY_DIRECTOR
References: