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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mauna Kea Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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