Pulmonary Nodule Cm
Conditions
Keywords
Lung nodule, PET scanner, Bronchoscopy, Electromagnetic navigation
Brief summary
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.
Interventions
PROCEDUREBronchoscopy
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.
Sponsors
European Lung Cancer Working Party
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capability of diagnosing lung nodule with ENB (Sensitivity) | After the procedure | Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of malignancy | After the procedure | 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 |
Countries
Belgium
Outcome results
None listed