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

Boston Children's Hospital

Status: Withdrawn

Conditions: Disorder Related to Lung Transplantation

Treatments: Device: Alveoflex Confocal MiniprobeTM

Study type: Interventional

Funder types: Other

Identifiers

NCT02395393

IRB-P00017377

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 6 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Lung transplant recipients

Other group

Description:

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.

Treatment:

Device: Alveoflex Confocal MiniprobeTM