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Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.

NCT ID: NCT02689102

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-28

Study Completion Date

2017-04-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Interstitial Lung Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ILD patients

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

Probe based optical techniques

Intervention Type 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.

Interventions

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Probe based optical techniques

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.

Intervention Type DEVICE

Other Intervention Names

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Confocal Laser Endomicroscopy (Mauna Kea technologies) Optical Coherence Tomography (St Jude medical)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Prof J.T. Annema

prof.dr. J.T. Annema

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jouke T Annema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Netherlands, Academisch Medisch Centrum

Locations

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Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL 54612.018.15

Identifier Type: -

Identifier Source: org_study_id