Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
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ClinicalTrials.gov Identifier: NCT01779388 |
Recruitment Status :
Recruiting
First Posted : January 30, 2013
Last Update Posted : June 26, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Nodule Cm | Procedure: Bronchoscopy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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. |
Actual Study Start Date : | January 2013 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Bronchoscopy guided by fluoroscopy
Bronchoscopy guided by fluoroscopy followed by ENG
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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. |
Experimental: Bronchoscopy guided by electromagnetic navigation
Bronchoscopy guided by ENG followed by fluoroscopy
|
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. |
- Capability of diagnosing lung nodule with ENB (Sensitivity) [ Time Frame: After the procedure ]Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule
- Prediction of malignancy [ Time Frame: 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779388
Contact: Thierry Berghmans, MD, PhD | 003225413191 | ||
Contact: Nathalie Leclercq, RN | 003225413192 | nathalie.leclercq@bordet.be |
Belgium | |
Institut Jules Bordet | Recruiting |
Brussels, Belgium, 1000 | |
Contact: Nathalie Leclercq, RN 003225413192 nathalie.leclercq@bordet.be | |
Principal Investigator: Thierry Berghmans, MD, PhD |
Study Chair: | Thierry Berghmans, MD, PhD | ELCWP | |
Principal Investigator: | Dimitri Leduc, MD, PhD | ELCWP |
Responsible Party: | European Lung Cancer Working Party |
ClinicalTrials.gov Identifier: | NCT01779388 |
Other Study ID Numbers: |
01201 |
First Posted: | January 30, 2013 Key Record Dates |
Last Update Posted: | June 26, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Lung nodule PET scanner Bronchoscopy Electromagnetic navigation |
Multiple Pulmonary Nodules Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |