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Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation

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ClinicalTrials.gov Identifier: NCT02395393
Recruitment Status : Recruiting
First Posted : March 23, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Levent Midyat, Boston Children’s Hospital

Brief Summary:
Bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. Confocal fluorescence microscopy is a novel technique used for real-time microscopic imaging of proximal and distal airways, microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy images of airways and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.

Condition or disease Intervention/treatment Phase
Disorder Related to Lung Transplantation Device: Alveoflex Confocal MiniprobeTM Not Applicable

Detailed Description:

Bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. Confocal fluorescence microscopy is a novel technique used for in vivo microscopic imaging of proximal and distal airways including bronchial and alveolar walls, microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.

The objectives and outcomes of this study are:

  1. To assess the safety of confocal microscopy imaging in pediatric patients
  2. To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
  3. To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
  4. Correlate confocal images to FEV1 results
  5. Correlate with CXRs and/or CT images

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Lung transplant recipients
In patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup, the investigators will offer the patient concurrent confocal microscopy imaging to be performed during the bronchoscopic procedure. A 1.4mm or 1.9mm diameter Alveoflex Confocal MiniprobeTM (MaunaKea Technologies, France) will be deployed down the working channel of the standard bronchoscope and advanced distally into the alveoli.
Device: Alveoflex Confocal MiniprobeTM
-Alveolar imaging




Primary Outcome Measures :
  1. Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies [ Time Frame: One year ]
    Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: One year ]
    Monitor for serious adverse events

  2. Correlation of confocal images with FEV1 results [ Time Frame: One year ]
    Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values



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Ages Eligible for Study:   6 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • to be older than six years of age
  • to be undergoing surveillance or clinically indicated bronchoscopies with transbronchial biopsy as part of their routine care
  • to be willing and able to comply with study procedures and provide written informed consent/assent to participate in the study

Exclusion Criteria:

  • to be unwilling to consent
  • to be unable to safely tolerate a bronchoscopic procedure
  • to have any contraindications to short-acting anesthetic agents
  • to have any contraindications to transbronchial biopsies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395393


Contacts
Contact: Levent Midyat, MD 617-355-1900 levent.midyat@childrens.harvard.edu
Contact: Kenan Haver, MD 617-355-1900 kenan.haver@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kenan Haver         
Sub-Investigator: Katie Krone, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Study Director: Gary Visner, DO Boston Children’s Hospital

Publications:
Responsible Party: Levent Midyat, MD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02395393     History of Changes
Other Study ID Numbers: IRB-P00017377
First Posted: March 23, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Levent Midyat, Boston Children’s Hospital:
Acute rejection
Chronic rejection
Confocal microscopy