Disorder Related to Lung TransplantationNCT02395393
Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
A study testing Alveoflex Confocal MiniprobeTM in people with Disorder Related to Lung Transplantation, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 22 years
- Conditions the study is for
- Disorder Related to Lung Transplantation
- What is being tested?
- Alveoflex Confocal MiniprobeTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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:
- To assess the safety of confocal microscopy imaging in pediatric patients
- To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
- To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
- Correlate confocal images to FEV1 results
- Correlate with CXRs and/or CT images
- Conditions
- Disorder Related to Lung Transplantation
- Being tested
- Alveoflex Confocal MiniprobeTM
- Keywords
- Acute rejection, Chronic rejection, Confocal microscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveoflex Confocal MiniprobeTMDevice
-Alveolar imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Alveoflex Confocal MiniprobeTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (2)
Number of participants with adverse events
Monitor for serious adverse events
Measured: One year
Correlation of confocal images with FEV1 results
Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study start1 Nov 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: This study is planned for later
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Midyat, Boston Children's Hospital
- Investigators
- Gary Visner, DO, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395393
- Sponsor's protocol ID
- IRB-P00017377
- Status last verified
- Sep 2021
- First submitted
- 10 Mar 2015
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16778275Hanson 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.
PubMed 937843Thiberville 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.
PubMed 19213792Yserbyt 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.
PubMed 23706778Thiberville 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.
PubMed 19687217
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
- ClinicalTrials.gov ID
- NCT02395393
- Acronym / sponsor ID
- IRB-P00017377
- Conditions
- Disorder Related to Lung Transplantation
- Keywords
- Acute rejection, Chronic rejection, Confocal microscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is planned for later
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the safety of confocal microscopy imaging in pediatric patients
- To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
- To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
- Correlate confocal images to FEV1 results
- Correlate with CXRs and/or CT images
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant recipients | Other | Device: Alveoflex Confocal MiniprobeTMIn 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. |
Who may qualify
- Ages
- 6 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveoflex Confocal MiniprobeTM-Alveolar imaging | Device | Lung transplant recipients |
Primary outcome
Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
Time frame: One year
Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection
2 secondary outcomes
Number of participants with adverse events
Time frame: One year
Correlation of confocal images with FEV1 results
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Background: PubMed 16778275Izbicki 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.
- Background: PubMed 937843Hanson 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.
- Background: PubMed 19213792Thiberville 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.
- Background: PubMed 23706778Yserbyt 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.
- Background: PubMed 19687217Thiberville 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Visner, DO study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveoflex Confocal MiniprobeTM in people with Disorder Related to Lung Transplantation, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.