Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-01 @ 11:27 AM
Study NCT ID:
NCT02395393
Status:
WITHDRAWN
Last Update Posted:
2021-09-10
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study is planned for later', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies', 'timeFrame': 'One year', 'description': 'Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'One year', 'description': 'Monitor for serious adverse events'}, {'measure': 'Correlation of confocal images with FEV1 results', 'timeFrame': 'One year', 'description': 'Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute rejection', 'Chronic rejection', 'Confocal microscopy'], 'conditions': ['Disorder Related to Lung Transplantation']}, 'referencesModule': {'references': [{'pmid': '16778275', 'type': 'BACKGROUND', '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.'}, {'pmid': '937843', 'type': 'BACKGROUND', '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.'}, {'pmid': '19213792', 'type': 'BACKGROUND', '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.'}, {'pmid': '23706778', 'type': 'BACKGROUND', '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.'}, {'pmid': '19687217', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe objectives and outcomes of this study are:\n\n1. To assess the safety of confocal microscopy imaging in pediatric patients\n2. To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation\n3. To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies\n4. Correlate confocal images to FEV1 results\n5. Correlate with CXRs and/or CT images'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be older than six years of age\n* to be undergoing surveillance or clinically indicated bronchoscopies with transbronchial biopsy as part of their routine care\n* to be willing and able to comply with study procedures and provide written informed consent/assent to participate in the study\n\nExclusion Criteria:\n\n* to be unwilling to consent\n* to be unable to safely tolerate a bronchoscopic procedure\n* to have any contraindications to short-acting anesthetic agents\n* to have any contraindications to transbronchial biopsies'}, 'identificationModule': {'nctId': 'NCT02395393', 'briefTitle': 'Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation', 'orgStudyIdInfo': {'id': 'IRB-P00017377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lung transplant recipients', 'description': '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.', 'interventionNames': ['Device: Alveoflex Confocal MiniprobeTM']}], 'interventions': [{'name': 'Alveoflex Confocal MiniprobeTM', 'type': 'DEVICE', 'description': '-Alveolar imaging', 'armGroupLabels': ['Lung transplant recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gary Visner, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Levent Midyat', 'investigatorAffiliation': "Boston Children's Hospital"}}}}