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Completed

NCT Number: NCT01779388

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jules Bordet

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

European Lung Cancer Working Party

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2013
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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