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

Not Applicable

Completed

• Conditions: Pulmonary Nodule Cm
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT01779388
• Lead Sponsor: European Lung Cancer Working Party

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Primary Completion: 2020-12
• Status Verified: 2021-08
• Study Completion: 2021-12
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchoscopy guided by electromagnetic navigation	Bronchoscopy	Bronchoscopy guided by ENG followed by fluoroscopy
Bronchoscopy guided by fluoroscopy	Bronchoscopy	Bronchoscopy guided by fluoroscopy followed by ENG

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium