Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.
The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pCLE for Discrete lung lesions | Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy |
| |
| pCLE for acute lung transplant rejection | Patients undergoing bronchoscopy for the detection of acute rejection of lung transplant with probe based laser endomicroscopy (pCLE) imaging before biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probe based laser endomicroscopy (pCLE) | Device | pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant. | For Group 1 - Discrete lung lesions | Up to 12 months |
| Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant. | For Group 2 - Transplant rejection | Up to 12 months. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects who are 18 years of age or older with a clinical indication for a Bronchoscopic procedure for:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cesar Keller, MD | Mayo Clinic | Principal Investigator |
| Kyle Hogarth, MD | University of Chicago | Principal Investigator |
| Doug Arenberg, MD | University of Michigan | Principal Investigator |
| Adam Wellikoff, MD | Louisiana State University Health Sciences Center Shreveport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21802675 | Background | Meining A, Chen YK, Pleskow D, Stevens P, Shah RJ, Chuttani R, Michalek J, Slivka A. Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience. Gastrointest Endosc. 2011 Nov;74(5):961-8. doi: 10.1016/j.gie.2011.05.009. Epub 2011 Jul 29. | |
| 21741642 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Jacksonville |
| Florida |
| 32082 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Columbus Regional Hospital | Columbus | Indiana | 47201 | United States |
| University of Louisiana Shreveport | Shreveport | Louisiana | 71130 | United States |
| Walter Reed Military Medical Center | Bethesda | Maryland | 20889 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Ohio State University | Columbus | Ohio | 43201 | United States |
| Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13. |
| 18755886 | Background | Pohl H, Rosch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28. |
| 22000588 | Background | Newton RC, Kemp SV, Yang GZ, Elson DS, Darzi A, Shah PL. Imaging parenchymal lung diseases with confocal endomicroscopy. Respir Med. 2012 Jan;106(1):127-37. doi: 10.1016/j.rmed.2011.09.009. Epub 2011 Oct 14. |
| 21699692 | Background | Yick CY, von der Thusen JH, Bel EH, Sterk PJ, Kunst PW. In vivo imaging of the airway wall in asthma: fibered confocal fluorescence microscopy in relation to histology and lung function. Respir Res. 2011 Jun 23;12(1):85. doi: 10.1186/1465-9921-12-85. |
| 19213792 | Background | 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. |
| 11443621 | Background | Henschke CI, Naidich DP, Yankelevitz DF, McGuinness G, McCauley DI, Smith JP, Libby D, Pasmantier M, Vazquez M, Koizumi J, Flieder D, Altorki N, Miettinen OS. Early lung cancer action project: initial findings on repeat screenings. Cancer. 2001 Jul 1;92(1):153-9. doi: 10.1002/1097-0142(20010701)92:13.0.co;2-s. |
| 21714641 | Background | National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. |
| 17291623 | Background | Ikeda N, Hayashi A, Iwasaki K, Honda H, Tsuboi M, Usuda J, Kato H. Comprehensive diagnostic bronchoscopy of central type early stage lung cancer. Lung Cancer. 2007 Jun;56(3):295-302. doi: 10.1016/j.lungcan.2007.01.009. Epub 2007 Feb 8. |
| 21980059 | Background | Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764. |
| 16873767 | Background | Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27. |
| Background | Wilson DS, Bartlett RJ. Improved Diagnostic Yield of Bronchoscopy in a Community Practice: Combination of Electromagnetic Navigation System and Rapid On-site Evaluation. Journal of Bronchology & Interventional Pulmonology 2007;14:227-232 10.1097/LBR.0b013e31815a7b00. |
| 22126413 | Background | Ohtani K, Lee AM, Lam S. Frontiers in bronchoscopic imaging. Respirology. 2012 Feb;17(2):261-9. doi: 10.1111/j.1440-1843.2011.02108.x. |
| 20610073 | Background | Salaun M, Bourg-Heckly G, Thiberville L. [Confocal endomicroscopy of the lung: from the bronchus to the alveolus]. Rev Mal Respir. 2010 Jun;27(6):579-88. doi: 10.1016/j.rmr.2009.12.009. Epub 2010 Jun 2. French. |
| 20431326 | Background | Thiberville L, Salaun M. Bronchoscopic advances: on the way to the cells. Respiration. 2010;79(6):441-9. doi: 10.1159/000313495. Epub 2010 May 12. |
| 23169014 | Background | Filner JJ, Bonura EJ, Lau ST, Abounasr KK, Naidich D, Morice RC, Eapen GA, Jimenez CA, Casal RF, Ost D. Bronchoscopic fibered confocal fluorescence microscopy image characteristics and pathologic correlations. J Bronchology Interv Pulmonol. 2011 Jan;18(1):23-30. doi: 10.1097/LBR.0b013e318203da1c. |
| 14619355 | Background | DeVito Dabbs A, Hoffman LA, Iacono AT, Wells CL, Grgurich W, Zullo TG, McCurry KR, Dauber JH. Pattern and predictors of early rejection after lung transplantation. Am J Crit Care. 2003 Nov;12(6):497-507. |
| 11568342 | Background | Gotway MB, Dawn SK, Sellami D, Golden JA, Reddy GP, Keith FM, Webb WR. Acute rejection following lung transplantation: limitations in accuracy of thin-section CT for diagnosis. Radiology. 2001 Oct;221(1):207-12. doi: 10.1148/radiol.2211010380. |
| 16244247 | Background | MacMahon H, Austin JH, Gamsu G, Herold CJ, Jett JR, Naidich DP, Patz EF Jr, Swensen SJ; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005 Nov;237(2):395-400. doi: 10.1148/radiol.2372041887. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided