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

NCT02961335 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Luc THIBERVILLE, Pr · University Hospital, Rouen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-02
Primary Completion
2022-09-13
Completion
2022-09-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961335 on ClinicalTrials.gov