Clinical trial NCT01779388: Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule Cm
Keywords: Lung nodule
PET scanner
Bronchoscopy
Electromagnetic navigation
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Capability of diagnosing lung nodule with ENB (Sensitivity)
timeFrame: After the procedure
Secondary outcomes:
measure: Prediction of malignancy
timeFrame: After the procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: ELCWP
name: Thierry Berghmans, MD, PhD
role: STUDY_CHAIR
affiliation: ELCWP
name: Dimitri Leduc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: