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

NCT02961335 | Terminated

• 1 other identifier: 2014/0208/HP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Parenchymal Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1

Study Arms (1)

Patient who need to undergo bronchoscopy

EXPERIMENTAL

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

Procedure: Bronchoscopy; Procedure: Confocal microendoscopy; Procedure: Biopsy sampling

Interventions

Bronchoscopy PROCEDURE

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

Patient who need to undergo bronchoscopy

Confocal microendoscopy PROCEDURE

Confocal microendoscopy will be performed during this initial bronchoscopy

Patient who need to undergo bronchoscopy

Biopsy sampling PROCEDURE

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

Patient who need to undergo bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• non-smoking or smoking cessation \>6 month
• Patient affiliated with, or beneficiary of a social security category

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Bronchoscopy; Chorionic Villi Sampling

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques

Study Officials

• Luc THIBERVILLE, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: December 2, 2018
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)