Benign Neoplasms of the Respiratory System Clinical Trial
Official title:
Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. "NODIVEM" Study
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.
Main assessment criteria:
1. number of lesions localized by confocal endoscopy compared to navigational bronchoscopy
2. Positive and negative predictive values of confocal signs before and after IV
fluorophore injection for the diagnosis of cancer.
In this this study, positive diagnostic criteria for the localization of peripheral nodule
using confocal imaging is a solid pattern as opposed to the usual loose fibered network
pattern of the normal alveolar duct. According to this criteria, the confocal imaging
procedure will be considered as valid if the number of lesions localized by confocal is not
inferior to 90 % of those localized by navigational bronchoscopy. Therefore, probe based
confocal laser endo-microscopy will prove valid if it can recognize at least 70 subjects out
of the 78 / 120 subjects for which the navigational bronchoscopy is forecasted to localize
the peripheral lesion (Cohen concordance Kappa value of 0,74 between confocal and
navigational bronchoscopy).
A secondary objective will be to describe specific signs of cancer using confocal endoscopy
. This will be assessed on the first 30 patients using confocal imaging obtained before and
after fluorophore IV injection, in comparison to histology, and confirmed on the following
48 patients.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic