Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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:
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To assess the safety of confocal microscopy imaging in pediatric patients
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To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
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To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
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Correlate confocal images to FEV1 results
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Correlate with CXRs and/or CT images
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies [One year]
Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection
Secondary Outcome Measures
- Number of participants with adverse events [One year]
Monitor for serious adverse events
- Correlation of confocal images with FEV1 results [One year]
Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values
Eligibility Criteria
Criteria
Inclusion Criteria:
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to be older than six years of age
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to be undergoing surveillance or clinically indicated bronchoscopies with transbronchial biopsy as part of their routine care
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to be willing and able to comply with study procedures and provide written informed consent/assent to participate in the study
Exclusion Criteria:
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to be unwilling to consent
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to be unable to safely tolerate a bronchoscopic procedure
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to have any contraindications to short-acting anesthetic agents
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to have any contraindications to transbronchial biopsies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Boston Children's Hospital
Investigators
- Study Director: Gary Visner, DO, Boston Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Hanson RR, Zavala DC, Rhodes ML, Keim LW, Smith JD. Transbronchial biopsy via flexible fiberoptic bronchoscope; results in 164 patients. Am Rev Respir Dis. 1976 Jul;114(1):67-72.
- Izbicki G, Shitrit D, Yarmolovsky A, Bendayan D, Miller G, Fink G, Mazar A, Kramer MR. Is routine chest radiography after transbronchial biopsy necessary?: A prospective study of 350 cases. Chest. 2006 Jun;129(6):1561-4.
- Thiberville L, Salaün M, Lachkar S, Dominique S, Moreno-Swirc S, Vever-Bizet C, Bourg-Heckly G. Confocal fluorescence endomicroscopy of the human airways. Proc Am Thorac Soc. 2009 Aug 15;6(5):444-9. doi: 10.1513/pats.200902-009AW. Review.
- Thiberville L, Salaün M, Lachkar S, Dominique S, Moreno-Swirc S, Vever-Bizet C, Bourg-Heckly G. Human in vivo fluorescence microimaging of the alveolar ducts and sacs during bronchoscopy. Eur Respir J. 2009 May;33(5):974-85. doi: 10.1183/09031936.00083708. Epub 2009 Feb 12.
- Yserbyt J, Dooms C, Decramer M, Verleden GM. Probe-based confocal laser endomicroscopy of the respiratory tract: a data consistency analysis. Respir Med. 2013 Aug;107(8):1234-40. doi: 10.1016/j.rmed.2013.04.018. Epub 2013 May 23.
- IRB-P00017377