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

NCT01931579 | Completed

• 2 other identifiers: 2011/103/HP2011-AO1053-38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Conditions

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

Keywords

confocal endo-microscopy, lung nodule, respiratory neoplasms

Outcome Measures

Primary Outcomes (1)

• Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule

  Confocal imaging will be considered as "positive" when both * a solid pattern is displayed * a diagnostic biopsy is obtained at the site of confocal imaging

  six months after the procedure

Study Arms (1)

confocal endo-microscopy

EXPERIMENTAL

confocal endo-microscopy : CELLVIZIO endo-microscopy procedure is performed in every patient using the same extended working channel as for navigational bronchoscopy.

Device: confocal endo-microscopy

Interventions

confocal endo-microscopy DEVICE

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.

Also known as: CELLVIZIO Lung 488 nm and 660 nm, 1 mm CELLVIZIO miniprobe (ALVEOFLEX), 0.6 mm CELLVIZIO miniprobe (CHOLANGIOFLEX)

confocal endo-microscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a peripheral lung nodule accessible by navigational bronchoscopy and CELLVIZIO according to Investigator evaluation of the CT scan.
• years old or more.
• Affiliation to french social security insurance.
• Signed informed consent for the procedure.

You may not qualify if:

• Severe respiratory insufficiency that will not allow the bronchoscopy procedure
• Uncorrected bleeding disorders
• History of pneumonectomy or exploration controlateral to a non functional lung,
• Pregnant or breast feeding woman, or person not authorized to participate to a clinical trial according to L1121-6 et L1121-8 of French Code of Public Health, concurrent participation to another clinical trial

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (3)

UHRouen

Rouen, 76031, France

Location

CHU Saint Etienne

Saint-Etienne, 42055, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

• Hassan T, Thiberville L, Hermant C, Lachkar S, Piton N, Guisier F, Salaun M. Assessing the feasibility of confocal laser endomicroscopy in solitary pulmonary nodules for different part of the lungs, using either 0.6 or 1.4 mm probes. PLoS One. 2017 Dec 21;12(12):e0189846. doi: 10.1371/journal.pone.0189846. eCollection 2017.

  PMID: 29267317 RESULT

• Hassan T, Piton N, Lachkar S, Salaun M, Thiberville L. A Novel Method for In Vivo Imaging of Solitary Lung Nodules Using Navigational Bronchoscopy and Confocal Laser Microendoscopy. Lung. 2015 Oct;193(5):773-8. doi: 10.1007/s00408-015-9769-8. Epub 2015 Jul 28.

  PMID: 26216723 RESULT

MeSH Terms

Conditions

Respiratory Tract Neoplasms

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Study Officials

• Luc C Thiberville, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 29, 2013
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (3)