Clinical trial NCT02395393: Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
Official title: Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Disorder Related to Lung Transplantation
Keywords: Acute rejection
Chronic rejection
Confocal microscopy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

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

Primary outcomes:
measure: Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
timeFrame: One year
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: One year
measure: Correlation of confocal images with FEV1 results
timeFrame: One year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Gary Visner, DO
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1378/chest.129.6.1561.
citation: 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. doi: 10.1164/arrd.1976.114.1.67.
citation: Thiberville L, Salaun 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.
citation: 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.
citation: Thiberville L, Salaun 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.