Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

Lung Neoplasms Clinical Trial

— CLEAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05231278
• Other study ID #: JJEI202101
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Enterprise Innovation Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 30, 2024
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Device:
• nCLE 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.

Locations

Country	Name	City	State
United States	Clinical Research Associates of Central PA	Altoona	Pennsylvania
United States	John Muir Health	Concord	California
United States	Fox Chase Cancer Center of the American Oncologic Hospital, Inc.	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Enterprise Innovation Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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