Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules

Study Overview
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Brief Summary
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Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing validation. the primary aim of the study is to compare ENB to radiologically guided bronchoscopy, considered the standard comparator.

Official Title
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Role of Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules of Indeterminate Nature. A Prospective Study by the European Lung Cancer Working Party.

Conditions
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Pulmonary Nodule Cm

Intervention / Treatment
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* Procedure: Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence on a conventional or low dose chest CT at least one lung nodule 5-20 mm in its largest axis, of indeterminate nature; the nodule must be positive at PET-CT examination (in case of PET-CT negative, only follow-up is proposed) The pulmonary nodule(s) must be known for less than 6 months The nodule appearance can be solid, presents as a ground glass opacity with solid component or as pure ground glass opacity Availability for participating in the detailed follow-up of the protocol Signed informed consent. Age > 18 years Exclusion Criteria: Nodules found in the context of an active infection or for whom, the clinical context and/or additional available investigations (serology, microbiological samplings, immune abnormalities) show that cancer diagnosis is unlikely Nodules found in the context of an active previously documented disease that can be associated with pulmonary nodules (anthracosilicosis, histoplasmosis, tuberculosis, autoimmune or rheumatoid diseases …) Calcified nodule Anticoagulation therapy of any type that cannot be suspended for the duration of the investigation Respiratory failure, recent myocardial infarction (less than 3 months prior to the date of lung nodule screening), uncontrolled angina pectoris, congestive cardiac failure, cardiac arrhythmia, uncontrolled infectious disease or any other physical, biological or psychological factor which may prevent adherence to the study protocol or which may impair the patient's tolerance to the endoscopy and/or the general anaesthesia Presence of a implanted cardiac device (pace-maker, defibrillator, …) Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bronchoscopy guided by fluoroscopy<br>Bronchoscopy guided by fluoroscopy followed by ENG | Procedure: Bronchoscopy<br>* During a general anaesthesia, an evaluation will be done by conventional bronchoscopy guided by fluoroscopy and by bronchial endoscopy guided by electromagnetic navigation, the selection of order in techniques being randomly assigned.<br>|
| Experimental: Bronchoscopy guided by electromagnetic navigation<br>Bronchoscopy guided by ENG followed by fluoroscopy | Procedure: Bronchoscopy<br>* During a general anaesthesia, an evaluation will be done by conventional bronchoscopy guided by fluoroscopy and by bronchial endoscopy guided by electromagnetic navigation, the selection of order in techniques being randomly assigned.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capability of diagnosing lung nodule with ENB (Sensitivity) | Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule | After the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of malignancy | To identify a predictive molecular signature able to predict the malignant nature of the nodule by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques in biopsies, alveolar lavage, blood and exhaled breath | After the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung nodule, PET scanner, Bronchoscopy, Electromagnetic navigation