Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses.

Summary

Solitary pulmonary nodule has become a major challenge in respiratory clinical practice. According to published guidelines, their management often requires close CT follow up, PET CT and invasive procedures to obtain a definite histology. In this context, innovative endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for the localization and sampling of peripheral lung nodules. However, these techniques are unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of the distal lung structures in real time.

This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral lung nodules and to differentiate benign from tumoral lesions.

Objective(s)

1. To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule
2. To demonstrate that confocal endoscopy can differentiate benign from malignant tumors

Experimental design:

Multicentric prospective controlled trial, conducted in three academic centers, specialized in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based confocal endo-microscopy.

Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted in the same catheter as used for the navigational bronchoscopy and confocal images will be recorded before sampling. An ancillary study using topical methylene blue as in situ will be conducted at the Rouen University Center.

An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal endo-microscopy analysis.

Conditions

• Pulmonary Nodule Persistent
• Malignant Neoplasm of the Respiratory System
• Benign Neoplasms of the Respiratory System

Interventions

DEVICE

confocal endo-microscopy

The intervention consists of the use of confocal endo-microscopy using the CELLVIZIO device and either the 1 mm CELLVIZIO miniprobe (ALVEOFLEX) or the 0.6 mm CELLVIZIO miniprobe (CHOLANGIOFLEX), during a navigational bronchoscopy procedure for the diagnostic of peripheral nodule. In this study, the navigational device - either radial endobronchial ultrasound (EBUS) or electromagnetic navigation (EMN) - will be moved to another location if the CELLVIZIO displays a non solid pattern, indicating that the nodule may not have been reached during the procedure. Three attempts of EBUS or EMN are allowed until the CELLVIZIO shows a solid pattern.

Sponsors & Collaborators

• University Hospital, Rouen

  lead OTHER

Principal Investigators

• Luc C Thiberville, MD · University Hospital, Rouen

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-12-31

Completion

2016-06-30

Countries

• France

Study Locations