Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
This study is currently recruiting participants.
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
European Lung Cancer Working Party
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Nodule Cm |
Procedure: Bronchoscopy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by European Lung Cancer Working Party:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Bronchoscopy guided by fluoroscopy
Bronchoscopy guided by fluoroscopy followed by ENG
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779388
Contacts
| Contact: Thierry Berghmans, MD, PhD | 003225413191 | |
| Contact: Nathalie Leclercq, RN | 003225413192 | nathalie.leclercq@bordet.be |
Locations
| Belgium | |
| Institut Jules Bordet | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Nathalie Leclercq, RN 003225413192 nathalie.leclercq@bordet.be | |
| Principal Investigator: Thierry Berghmans, MD, PhD | |
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
| Study Chair: | Thierry Berghmans, MD, PhD | ELCWP |
| Principal Investigator: | Dimitri Leduc, MD, PhD | ELCWP |
More Information
Additional Information:
ELCWP site 
No publications provided
| Responsible Party: | European Lung Cancer Working Party |
| ClinicalTrials.gov Identifier: | NCT01779388 History of Changes |
| Other Study ID Numbers: | 01201 |
| Study First Received: | January 28, 2013 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by European Lung Cancer Working Party:
|
Lung nodule PET scanner Bronchoscopy Electromagnetic navigation |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013