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OpenTrials
Completed

NCT Number: NCT02689102

Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.

Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. In clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ILD could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location.

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Key information

Conditions

Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

About this study

Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore, immediate validation of optical measurements during a biopsy is possible. Optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant.

Hypothesis: Novel optical techniques (pCLE and pOCT) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ILD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age
  • Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy

Exclusion criteria

  • Smoked in the last 6 months
  • Inability and willingness to provide informed consent
  • Inability to comply with the study protocol

Treatment and study plan

Probe based optical techniques

Device

During the diagnostic bronchoscopy, optical biopsy of the mucosa and alveolar compartment will be conducted by two different probe based optical techniques (Confocal Laser Endomicroscopy (Mauna Kea technologies) and Optical Coherence Tomography (St Jude Medical)). After the study measurements a biopsy will be obtained in the same area.

Other names: Confocal Laser Endomicroscopy (Mauna Kea technologies), Optical Coherence Tomography (St Jude medical)

Primary outcomes

  1. Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.

    Time frame: cross sectional (1 day)

Secondary outcomes

  1. (um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).

    Time frame: cross-sectional (1 day)

  2. Size of the alveolar openings (um), thickness of the alveolar septum/alveolar openings on pOCT imaging of the alveolar compartment (um).

    Time frame: cross-sectional (1day)

  3. Feasibility of pOCT alveolar compartment: measuring number of alveoli, trajectory in OCT pull-back with alveoli (mm), number of study-related adverse events.

    Time frame: cross-sectional (1 day)

  4. Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))

    Time frame: cross-sectional (1 day)

  5. Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)

    Time frame: cross-sectional (1 day)

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

Confocal Laser Endomicroscopy and OCT for Diagnosing ILD, a Comparison With Imaging and Pathology.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2016
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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