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

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ClinicalTrials.gov Identifier: NCT01793246
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Mauna Kea Technologies

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.

Condition or disease Intervention/treatment
Lung Neoplasms Disorder Related to Lung Transplantation Device: probe based laser endomicroscopy (pCLE)

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
Study Start Date : February 2013
Actual Primary Completion Date : December 24, 2016
Actual Study Completion Date : December 24, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
Other Names:
  • Cellvizio
  • pCLE
  • probe based confocal laser endomicroscopy
  • optical biopsy
  • optical endomicroscopy

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)
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
Other Names:
  • Cellvizio
  • pCLE
  • probe based confocal laser endomicroscopy
  • optical biopsy
  • optical endomicroscopy




Primary Outcome Measures :
  1. Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant. [ Time Frame: Up to 12 months ]
    For Group 1 - Discrete lung lesions

  2. Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant. [ Time Frame: Up to 12 months. ]
    For Group 2 - Transplant rejection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793246


Locations
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United States, Arizona
St. Joseph's Medical Center
Phoenix, Arizona, United States, 85013
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32082
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Columbus Regional Hospital
Columbus, Indiana, United States, 47201
United States, Louisiana
University of Louisiana Shreveport
Shreveport, Louisiana, United States, 71130
United States, Maryland
Walter Reed Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43201
Sponsors and Collaborators
Mauna Kea Technologies
Investigators
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Principal Investigator: 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

Publications:
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.

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Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT01793246    
Other Study ID Numbers: MKT_2012_lung_01
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Keywords provided by Mauna Kea Technologies:
lung cancer
lung neoplasms
lung transplant
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases