Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo
NCT ID: NCT01033201
Last Updated: 2012-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
71 participants
OBSERVATIONAL
2008-04-30
2011-03-31
Brief Summary
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Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar pathological conditions in real time. Specifically, we hypothesize that confocal endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help to recognize and classify the presence/absence of acute rejection and/or bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also identify the histological characteristics lung diseases such as interstitial, obstructive or vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate diagnosis of these lung conditions during routine bronchoscopies.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Lung transplant
All lung transplant patients presenting for screening/surveillance and diagnostic bronchoscopies at Mayo Clinic Florida are eligible for participation.
Confocal imaging
At the time of the standard of care bronchoscopy, confocal images will be obtained from each consented patient.
Interventions
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Confocal imaging
At the time of the standard of care bronchoscopy, confocal images will be obtained from each consented patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Any patient undergoing surveillance or clinically indicated bronchoscopies during or after lung transplantation
3. Any patient undergoing bronchoscopy prior lung transplant
Exclusion Criteria
2. Unable to safely tolerate a bronchoscopic procedure
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic Florida
Locations
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Mayo Clinic Florida
Jacksonville, Florida, United States
Countries
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References
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St Croix CM, Leelavanichkul K, Watkins SC. Intravital fluorescence microscopy in pulmonary research. Adv Drug Deliv Rev. 2006 Sep 15;58(7):834-40. doi: 10.1016/j.addr.2006.07.007. Epub 2006 Aug 11.
Herth FJ, Eberhardt R, Ernst A. The future of bronchoscopy in diagnosing, staging and treatment of lung cancer. Respiration. 2006;73(4):399-409. doi: 10.1159/000093369.
Trulock EP, Christie JD, Edwards LB, Boucek MM, Aurora P, Taylor DO, Dobbels F, Rahmel AO, Keck BM, Hertz MI. Registry of the International Society for Heart and Lung Transplantation: twenty-fourth official adult lung and heart-lung transplantation report-2007. J Heart Lung Transplant. 2007 Aug;26(8):782-95. doi: 10.1016/j.healun.2007.06.003. No abstract available.
Moffatt SD, Demers P, Robbins RC, Doyle R, Wienacker A, Henig N, Theodore J, Reitz BA, Whyte RI. Lung transplantation: a decade of experience. J Heart Lung Transplant. 2005 Feb;24(2):145-51. doi: 10.1016/j.healun.2003.10.020.
Sibley RK, Berry GJ, Tazelaar HD, Kraemer MR, Theodore J, Marshall SE, Billingham ME, Starnes VA. The role of transbronchial biopsies in the management of lung transplant recipients. J Heart Lung Transplant. 1993 Mar-Apr;12(2):308-24.
Bowdish ME, Arcasoy SM, Wilt JS, Conte JV, Davis RD, Garrity ER, Hertz ML, Orens JB, Rosengard BR, Barr ML. Surrogate markers and risk factors for chronic lung allograft dysfunction. Am J Transplant. 2004 Jul;4(7):1171-8. doi: 10.1111/j.1600-6143.2004.00483.x.
Colombat M, Groussard O, Lautrette A, Thabut G, Marrash-Chahla R, Brugiere O, Mal H, Leseche G, Fournier M, Degott C. Analysis of the different histologic lesions observed in transbronchial biopsy for the diagnosis of acute rejection. Clinicopathologic correlations during the first 6 months after lung transplantation. Hum Pathol. 2005 Apr;36(4):387-94. doi: 10.1016/j.humpath.2005.01.022.
Khalifah AP, Hachem RR, Chakinala MM, Yusen RD, Aloush A, Patterson GA, Mohanakumar T, Trulock EP, Walter MJ. Minimal acute rejection after lung transplantation: a risk for bronchiolitis obliterans syndrome. Am J Transplant. 2005 Aug;5(8):2022-30. doi: 10.1111/j.1600-6143.2005.00953.x.
Hachem RR, Yusen RD, Chakinala MM, Meyers BF, Lynch JP, Aloush AA, Patterson GA, Trulock EP. A randomized controlled trial of tacrolimus versus cyclosporine after lung transplantation. J Heart Lung Transplant. 2007 Oct;26(10):1012-8. doi: 10.1016/j.healun.2007.07.027.
Tazelaar HD, Nilsson FN, Rinaldi M, Murtaugh P, McDougall JC, McGregor CG. The sensitivity of transbronchial biopsy for the diagnosis of acute lung rejection. J Thorac Cardiovasc Surg. 1993 Apr;105(4):674-8.
Yousem SA, Berry GJ, Cagle PT, Chamberlain D, Husain AN, Hruban RH, Marchevsky A, Ohori NP, Ritter J, Stewart S, Tazelaar HD. Revision of the 1990 working formulation for the classification of pulmonary allograft rejection: Lung Rejection Study Group. J Heart Lung Transplant. 1996 Jan;15(1 Pt 1):1-15.
Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. doi: 10.1016/s1053-2498(02)00398-4. No abstract available.
Kiesslich R, Burg J, Vieth M, Gnaendiger J, Enders M, Delaney P, Polglase A, McLaren W, Janell D, Thomas S, Nafe B, Galle PR, Neurath MF. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology. 2004 Sep;127(3):706-13. doi: 10.1053/j.gastro.2004.06.050.
Thiberville L, Moreno-Swirc S, Vercauteren T, Peltier E, Cave C, Bourg Heckly G. In vivo imaging of the bronchial wall microstructure using fibered confocal fluorescence microscopy. Am J Respir Crit Care Med. 2007 Jan 1;175(1):22-31. doi: 10.1164/rccm.200605-684OC. Epub 2006 Oct 5.
Pacurariu RI. Low incidence of side effects following intravenous fluorescein angiography. Ann Ophthalmol. 1982 Jan;14(1):32-6.
Other Identifiers
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ACA00001534
Identifier Type: -
Identifier Source: secondary_id
08-000800
Identifier Type: -
Identifier Source: org_study_id
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