Pulmonary Nodule PersistentNODIVEMNCT01931579
Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses.
A study testing confocal endo-microscopy in people with Pulmonary Nodule Persistent and Malignant Neoplasm of the Respiratory System, run by University Hospital, Rouen at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule Persistent, Malignant Neoplasm of the Respiratory System, Benign Neoplasms of the Respiratory System
- What is being tested?
- confocal endo-microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- May 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
UHRouen
Rouen, 76031
CHU Saint Etienne
Saint-Etienne, 42055
CHU Toulouse
Toulouse, 31059
About this study
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.
Read more
Objective(s)
- To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule
- 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.
Read the detailed description
Main assessment criteria:
- number of lesions localized by confocal endoscopy compared to navigational bronchoscopy
- 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.
- Conditions
- Pulmonary Nodule Persistent, Malignant Neoplasm of the Respiratory System, Benign Neoplasms of the Respiratory System
- Being tested
- confocal endo-microscopy
- Keywords
- confocal endo-microscopy, lung nodule, respiratory neoplasms
- Medical subject headings
- Respiratory Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
confocal endo-microscopyDevice
Also called CELLVIZIO Lung 488 nm and 660 nm, 1 mm CELLVIZIO miniprobe (ALVEOFLEX), 0.6 mm CELLVIZIO miniprobe (CHOLANGIOFLEX)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: confocal endo-microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule PersistentStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc C Thiberville, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931579
- Sponsor's protocol ID
- 2011/103/HP
- Other IDs
- 2011-AO1053-38
- Acronym
- NODIVEM
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2013
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29267317Hassan 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.
PubMed 26216723
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. "NODIVEM" Study
- ClinicalTrials.gov ID
- NCT01931579
- Acronym / sponsor ID
- NODIVEM / 2011/103/HP
- Conditions
- Pulmonary Nodule Persistent, Malignant Neoplasm of the Respiratory System, Benign Neoplasms of the Respiratory System
- Keywords
- confocal endo-microscopy, lung nodule, respiratory neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule
- 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.
Detailed description
Main assessment criteria:
- number of lesions localized by confocal endoscopy compared to navigational bronchoscopy
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| confocal endo-microscopy | Experimental | Device: confocal endo-microscopyconfocal endo-microscopy : CELLVIZIO endo-microscopy procedure is performed in every patient using the same extended working channel as for navigational bronchoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| confocal endo-microscopyAlso: CELLVIZIO Lung 488 nm and 660 nm, 1 mm CELLVIZIO miniprobe (ALVEOFLEX), 0.6 mm CELLVIZIO miniprobe (CHOLANGIOFLEX)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. | Device | confocal endo-microscopy |
Primary outcome
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
Time frame: six months after the procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 29267317Hassan 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.
- Results publication: PubMed 26216723Hassan 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.
Related trials for Pulmonary Nodule Persistent
RecruitingObservational study
Multi-omics Detection Techniques for Differentiating Benign and Malignant Pulmonary Nodules
Lung Cancer (Diagnosis), Pulmonary Nodule Persistent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc C Thiberville, MD principal investigator
University Hospital, Rouen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing confocal endo-microscopy in people with Pulmonary Nodule Persistent and Malignant Neoplasm of the Respiratory System, run by University Hospital, Rouen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule (time frame: six months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.