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

Disorder Related to Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02395393
• Other study ID #: IRB-P00017377
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: September 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorder Related to Lung Transplantation

Intervention

Device:
• Alveoflex Confocal MiniprobeTM
-Alveolar imaging

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies	Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection	One year
Secondary	Number of participants with adverse events	Monitor for serious adverse events	One year
Secondary	Correlation of confocal images with FEV1 results	Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values	One year