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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT01779388
First received: January 28, 2013
Last updated: January 29, 2013
Last verified: January 2013

January 28, 2013
January 29, 2013
January 2013
December 2018   (final data collection date for primary outcome measure)
Capability of diagnosing lung nodule with ENB (Sensitivity) [ Time Frame: After the procedure ] [ Designated as safety issue: Yes ]
Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule
Same as current
Complete list of historical versions of study NCT01779388 on ClinicalTrials.gov Archive Site
Prediction of malignancy [ Time Frame: After the procedure ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pulmonary Nodule Cm
Procedure: Bronchoscopy
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.
  • Bronchoscopy guided by fluoroscopy
    Bronchoscopy guided by fluoroscopy followed by ENG
    Intervention: Procedure: Bronchoscopy
  • Experimental: Bronchoscopy guided by electromagnetic navigation
    Bronchoscopy guided by ENG followed by fluoroscopy
    Intervention: Procedure: Bronchoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2019
December 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Thierry Berghmans, MD, PhD 003225413191
Contact: Nathalie Leclercq, RN 003225413192 nathalie.leclercq@bordet.be
Belgium
 
NCT01779388
01201
No
European Lung Cancer Working Party
European Lung Cancer Working Party
Not Provided
Study Chair: Thierry Berghmans, MD, PhD ELCWP
Principal Investigator: Dimitri Leduc, MD, PhD ELCWP
European Lung Cancer Working Party
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP