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Clinical Trials/NCT01779388
NCT01779388CompletedNot Applicable

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.

European Lung Cancer Working Party2 sites in 1 country120 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
Capability of diagnosing lung nodule with ENB (Sensitivity)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

  • Prediction of malignancy(After the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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