- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779388
Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
March 22, 2022 updated by: European Lung Cancer Working Party
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Bronchoscopy guided by fluoroscopy
Bronchoscopy guided by fluoroscopy followed by ENG
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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.
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EXPERIMENTAL: Bronchoscopy guided by electromagnetic navigation
Bronchoscopy guided by ENG followed by fluoroscopy
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capability of diagnosing lung nodule with ENB (Sensitivity)
Time Frame: After the procedure
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Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule
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After the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prediction of malignancy
Time Frame: After the procedure
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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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After the procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dimitri Leduc, MD, PhD, ELCWP
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2013
Primary Completion (ACTUAL)
December 1, 2020
Study Completion (ACTUAL)
December 1, 2021
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (ESTIMATE)
January 30, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 4, 2022
Last Update Submitted That Met QC Criteria
March 22, 2022
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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