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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pulmonary Nodule Cm

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Capability of diagnosing lung nodule with ENB (Sensitivity)

Outcome Description:

Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule

Outcome Time Frame:

After the procedure

Safety Issue:

Yes

Principal Investigator

Thierry Berghmans, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

ELCWP

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

01201

NCT ID:

NCT01779388

Start Date:

January 2013

Completion Date:

December 2019

Related Keywords:

  • Pulmonary Nodule Cm
  • Lung nodule
  • PET scanner
  • Bronchoscopy
  • Electromagnetic navigation
  • Lung Neoplasms

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