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.
Conditions
Disorder Related to Lung Transplantation
Recruitment Status
Withdrawn
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: To assess the safety of confocal microscopy imaging in pediatric patients To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies Correlate confocal images to FEV1 results Correlate with CXRs and/or CT images
Eligibility 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
Intervention
Intervention Type
Intervention Name
Device
Alveoflex Confocal MiniprobeTM
Phase
Not Applicable
Gender
All
Min Age
6 Years
Max Age
22 Years
Download Date
September 10, 2021
Principal Investigator
Levent Midyat
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: