NCT02395393

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
3.6 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 10, 2015

Last Update Submit

September 2, 2021

Conditions

Disorder Related to Lung Transplantation

Keywords

Acute rejectionChronic rejectionConfocal microscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of participants with adverse events

    One year

  • Correlation of confocal images with FEV1 results

    One year

Study Arms (1)

Lung transplant recipients

OTHER

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

Interventions

Alveoflex Confocal MiniprobeTMDEVICE

-Alveolar imaging

Lung transplant recipients

Eligibility Criteria

Age6 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

  • 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.

    PMID: 16778275BACKGROUND

  • 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.

    PMID: 937843BACKGROUND

  • 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.

    PMID: 19213792BACKGROUND

  • 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.

    PMID: 23706778BACKGROUND

  • 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.

    PMID: 19687217BACKGROUND

Study Officials

  • Gary Visner, DO

    Boston Children's Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 23, 2015

Study Start

November 1, 2018

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

US(1)