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

August 28, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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
  • optical biopsy
  • probe based confocal laser endomicroscopy
  • 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
  • optical biopsy
  • probe based confocal laser endomicroscopy
  • optical endomicroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 months
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
Up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauna Kea Technologies

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 24, 2016

Study Completion (Actual)

December 24, 2016

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKT_2012_lung_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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