Clinical trial · Interventional
Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses.
Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. "NODIVEM" Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasms of the Respiratory System | — | UNRESOLVED | — |
| Malignant Neoplasm of the Respiratory System | — | UNRESOLVED | — |
| Pulmonary Nodule Persistent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| confocal endo-microscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- confocal endo-microscopy
- description
- confocal endo-microscopy : CELLVIZIO endo-microscopy procedure is performed in every patient using the same extended working channel as for navigational bronchoscopy.
- interventionNames
- Device: confocal endo-microscopy
Primary outcomes (1)
- measure
- Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
- timeFrame
- six months after the procedure
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTHassan 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
- RESULTHassan 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