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Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases

Study Purpose

Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological presentations. High resolution Chest CT, a key diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations, so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling. This invasive procedure is not devoid of morbidity and may be impossible to perform in fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a multi-disciplinary expert consensus, based on careful medical history, chest CT and bronchoalveolar lavage examinations. Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and confirmed the safety of the technique.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - age ≥ 18.
  • - signed written informed consent.
  • - indication for a flexible bronchoscopy.
  • - DPLD characterized by clinical and radiological data compatible with : idiopathic pulmonary fibrosis (IPF), acute or chronic hypersensitivity pneumonitis (HPS), sarcoidosis, or asbestosis.
  • - Initial histological confirmation of the disease is not required for the inclusion of the patient and the realisation of the alveolar bronchoscopy.
  • - non-smoking or smoking cessation >6 month.
  • - Patient affiliated with, or beneficiary of a social security category.

Exclusion Criteria:

  • - respiratory failure and contraindication for a flexible bronchoscopy (this item will stay at the appreciation of the physician, arterial blood gaz sampling being not required) - bleeding disorder which would be not compatible with the realization of a flexible bronchoscopy.
  • - history of pneumonectomy or non functional lung controlateral to the pCLE procedure.
  • - patients for which a per-endoscopic distal lung cryobiopsy is forecasted during the first diagnostic bronchoscopy, - patients for which the bronchoscopy needs a general anesthesia and mechanical ventilation during the procedure.
  • - anticoagulant or platelet aggregation inhibitors that cannot be interrupted for the flexible bronchoscopy.
  • - patients for which a follow up or an adequate work-up to achieve the final diagnosis will not be possible.
  • - patients for which a cryobiopsy is forecasted during the bronchoscopy.
  • - pregnant and breast feeding women, or women of childbearing potential not taking adequate contraception.
  • - Patients unable to understand informed consent.
  • - Patient on major legal measure of protection.
- Patients participating in an other interventional clinical trial at the inclusion date

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02961335
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital, Rouen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Luc THIBERVILLE, Pr
Principal Investigator Affiliation Rouen University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Diffuse Parenchymal Lung Diseases
Arms & Interventions

Arms

Experimental: Patient who need to undergo bronchoscopy

Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done

Interventions

Procedure: - Bronchoscopy

Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done

Procedure: - Confocal microendoscopy

Confocal microendoscopy will be performed during this initial bronchoscopy

Procedure: - Biopsy sampling

Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rouen University Hospital, Rouen, France

Status

Address

Rouen University Hospital

Rouen, ,

Site Contact

Luc THIBERVILLE, Pr

luc.thiberville@chu-rouen.fr

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