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Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases (Microsemio-PI)

Primary Purpose

Diffuse Parenchymal Lung Diseases

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bronchoscopy
Confocal microendoscopy
Biopsy sampling
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diffuse Parenchymal Lung Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient who need to undergo bronchoscopy

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
Confocal imaging will be considered as "positive" when both a solid pattern is displayed a diagnostic biopsy is obtained at the site of confocal imaging

Secondary Outcome Measures

Full Information

First Posted
November 8, 2016
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02961335
Brief Title
Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases
Acronym
Microsemio-PI
Official Title
Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases : A Multicentric Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Parenchymal Lung Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient who need to undergo bronchoscopy
Arm Type
Experimental
Arm Description
Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
Intervention Type
Procedure
Intervention Name(s)
Confocal microendoscopy
Intervention Description
Confocal microendoscopy will be performed during this initial bronchoscopy
Intervention Type
Procedure
Intervention Name(s)
Biopsy sampling
Intervention Description
Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
Primary Outcome Measure Information:
Title
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
Description
Confocal imaging will be considered as "positive" when both a solid pattern is displayed a diagnostic biopsy is obtained at the site of confocal imaging
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc THIBERVILLE, Pr
Email
luc.thiverville@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc THIBERVILLE, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc THIBERVILLE, Pr
Email
luc.thiberville@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Luc THIBERVILLE, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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