Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung (BREATH)
28. august 2017 oppdatert av: Mauna Kea Technologies
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
99
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85013
- St. Joseph's Medical Center
-
-
Florida
-
Jacksonville, Florida, Forente stater, 32082
- Mayo Clinic
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60637
- University of Chicago
-
-
Indiana
-
Columbus, Indiana, Forente stater, 47201
- Columbus Regional Hospital
-
-
Louisiana
-
Shreveport, Louisiana, Forente stater, 71130
- University of Louisiana Shreveport
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20889
- Walter Reed Military Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan
-
-
New York
-
Rochester, New York, Forente stater, 14642
- University of Rochester
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43201
- Ohio State University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects who are 18 years of age or older with a clinical indication for a Bronchoscopic procedure for:
- Discrete Lung Lesions
- Surveillance or Symptoms of Acute Rejection in Lung Transplants
Beskrivelse
Inclusion Criteria:
- Male or female > 18 years of age
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
- Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy
- Newly discovered &/or prior discovered non classified nodules, hard to define based on CT scan
- Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions
- All lesion locations are acceptable
- Any patient undergoing clinically indicated bronchoscopies after lung transplantation
- Patients post transplant showing clinical signs of acute rejection >3 weeks; < 1 year
- Patient with single or double lung transplant
Exclusion Criteria:
- Contraindication to short-acting anesthetic agents;
- Contraindications to transbronchial biopsy
- Bleeding diathesis;
- A pacemaker/defibrillator;
- A diagnosis by other means (sputum cytology, microbiology).
- Unwilling To Consent
- Unable To Safely Tolerate A Bronchoscopic Procedure
- Unwilling To Comply With Surveillance Bronchoscopy Follow Up
- Chronic Rejection
- Fungal Disease
- Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A Screen Failure
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
pCLE for Discrete lung lesions
Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy
|
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
Andre navn:
|
|
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
|
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.
Tidsramme: Up to 12 months
|
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.
Tidsramme: Up to 12 months.
|
For Group 2 - Transplant rejection
|
Up to 12 months.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Cesar Keller, MD, Mayo Clinic
- Hovedetterforsker: Kyle Hogarth, MD, University of Chicago
- Hovedetterforsker: Doug Arenberg, MD, University of Michigan
- Hovedetterforsker: Adam Wellikoff, MD, Louisiana State University Health Sciences Center Shreveport
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
24. desember 2016
Studiet fullført (Faktiske)
24. desember 2016
Datoer for studieregistrering
Først innsendt
14. februar 2013
Først innsendt som oppfylte QC-kriteriene
14. februar 2013
Først lagt ut (Anslag)
15. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MKT_2012_lung_01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .