Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.

NCT02689102 | Completed

• 1 other identifier: NL 54612.018.15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interstitial Lung Diseases

Keywords

Optical coherence tomography; Confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

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

  cross sectional (1 day)

Secondary Outcomes (5)

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

  cross-sectional (1 day)

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

  cross-sectional (1day)

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

  cross-sectional (1 day)

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

  cross-sectional (1 day)

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

  cross-sectional (1 day)

Study Arms (1)

ILD patients

ILD patients scheduled for diagnostic bronchoscopy with biopsy and/or broncho-alveolar lavage will undergo additional imagaing with probe based optical techniques.

Device: Probe based optical techniques

Interventions

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.

Also known as: Confocal Laser Endomicroscopy (Mauna Kea technologies), Optical Coherence Tomography (St Jude medical)

ILD patients

Eligibility Criteria

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

Study Population

Patients of 18 years or older (n=20), who are suspected for ILD based on imaging (HRCT-scan) and with an indication for bronchoscopy with cryobiopsy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Jouke T Annema, MD, PhD

  Netherlands, Academisch Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr. J.T. Annema

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 23, 2016
• Study Start: October 28, 2015
• Primary Completion: April 22, 2017
• Study Completion: April 22, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)