Clinical trial NCT01793246: Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
Official title: Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Disorder Related to Lung Transplantation
Keywords: lung cancer
lung neoplasms
lung transplant
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.
timeFrame: Up to 12 months
measure: Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant.
timeFrame: Up to 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Medical Center
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Columbus
country: United States
facility: Columbus Regional Hospital
state: Indiana
city: Shreveport
country: United States
facility: University of Louisiana Shreveport
state: Louisiana
city: Bethesda
country: United States
facility: Walter Reed Military Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Mayo Clinic
name: Cesar Keller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Kyle Hogarth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Doug Arenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Sciences Center Shreveport
name: Adam Wellikoff, MD
role: PRINCIPAL_INVESTIGATOR
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