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Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy (CLEAR)

Primary Purpose

Lung Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

nCLE aided RANB biospy

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Peripheral pulmonary nodule, Needle-based confocal laser endomicroscopy, Robotic-assisted bronchoscopy, Monarch

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

John Muir HealthRecruiting
Clinical Research Associates of Central PA
University of Pennsylvania
Fox Chase Cancer Center of the American Oncologic Hospital, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nCLE aided RANB biopsy

Arm Description

Single arm study

Outcomes

Primary Outcome Measures

'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.

Secondary Outcome Measures

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.

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.

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- 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.

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.

Full Information

NCT ID

NCT05231278

First Posted

January 28, 2022

Last Updated

October 9, 2023

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05231278

Brief Title

Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

Acronym

CLEAR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Enterprise Innovation Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

Peripheral pulmonary nodule, Needle-based confocal laser endomicroscopy, Robotic-assisted bronchoscopy, Monarch

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nCLE aided RANB biopsy

Arm Type

Experimental

Arm Description

Single arm study

Intervention Type

Device

Intervention Name(s)

nCLE aided RANB biospy

Intervention Description

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.

Primary Outcome Measure Information:

Title

'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy.

Description

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

Secondary Outcome Measure Information:

Title

Sensitivity of the real-time nCLE imaging assessment for malignancy

Description

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

Title

Diagnostic yield

Description

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

Title

Sensitivity of the post-procedure nCLE image assessment for malignancy

Description

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

Title

Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy

Description

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

Title

Safety of nCLE aided RANB biopsy procedure

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yina Kuang, PhD

ykuang5@its.jnj.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Balaji Laxmanan, MD

Organizational Affiliation

Johnson & Johnson Enterprise Innovation Inc.

Official's Role

Study Director

Facility Information:

Facility Name

John Muir Health

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suzanne Clements

First Name & Middle Initial & Last Name & Degree

Wilson Tsai, MD

Facility Name

Clinical Research Associates of Central PA

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Individual Site Status

Terminated

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle Andronov

First Name & Middle Initial & Last Name & Degree

David DiBardino, MD

Facility Name

Fox Chase Cancer Center of the American Oncologic Hospital, Inc.

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19129

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Manley, MD

12. IPD Sharing Statement

Learn more about this trial

Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

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