Pulmonary Nodule Cm Clinical Trial
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.
| NCT number | NCT01779388 |
| Other study ID # | 01201 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | December 2021 |
| Verified date | August 2021 |
| Source | European Lung Cancer Working Party |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Institut Jules Bordet | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| European Lung Cancer Working Party |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Capability of diagnosing lung nodule with ENB (Sensitivity) | Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule | After the procedure | |
| Secondary | Prediction of malignancy | 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 | After the procedure |