Benign Neoplasms of the Respiratory System Clinical Trial
— NODIVEMOfficial 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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with a peripheral lung nodule accessible by navigational bronchoscopy and CELLVIZIO according to Investigator evaluation of the CT scan. - 18 years old or more. - Affiliation to french social security insurance. - Signed informed consent for the procedure. Exclusion Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | UHRouen | Rouen | |
| France | CHU Saint Etienne | St ETIENNE | |
| France | CHU Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |