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

European Lung Cancer Working Party

Status

Completed

Conditions

Pulmonary Nodule Cm

Treatments

Procedure: Bronchoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01779388

01201

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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