Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung

NCT01793246 | Completed

• 1 other identifier: MKT_2012_lung_01
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Lung Neoplasms; Disorder Related to Lung Transplantation

Keywords

lung cancer; lung neoplasms; lung transplant

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

pCLE for Discrete lung lesions

Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy

Device: probe based laser endomicroscopy (pCLE)

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

Device: probe based laser endomicroscopy (pCLE)

Interventions

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.

Also known as: Cellvizio, pCLE, probe based confocal laser endomicroscopy, optical biopsy, optical endomicroscopy

pCLE for Discrete lung lesions; pCLE for acute lung transplant rejection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mauna Kea Technologies: lead

Study Sites (9)

St. Joseph's Medical Center

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic

Jacksonville, Florida, 32082, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Columbus Regional Hospital

Columbus, Indiana, 47201, United States

Location

University of Louisiana Shreveport

Shreveport, Louisiana, 71130, United States

Location

Walter Reed Military Medical Center

Bethesda, Maryland, 20889, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Ohio State University

Columbus, Ohio, 43201, United States

Location

Related Publications (19)

• 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.

  PMID: 21802675 BACKGROUND

• 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.

  PMID: 21741642 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.

  PMID: 18755886 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.

  PMID: 22000588 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.

  PMID: 21699692 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.

  PMID: 19213792 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.

  PMID: 11443621 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.

  PMID: 21714641 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.

  PMID: 17291623 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.

  PMID: 21980059 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.

  PMID: 16873767 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.

  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.

  PMID: 22126413 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.

  PMID: 20610073 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.

  PMID: 20431326 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.

  PMID: 23169014 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.

  PMID: 14619355 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.

  PMID: 11568342 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.

  PMID: 16244247 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: December 24, 2016
• Study Completion: December 24, 2016
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

US (9)