Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
This trial is active, not recruiting.
|Conditions||lung neoplasms, disorder related to lung transplantation|
|Treatment||probe based laser endomicroscopy (pcle)|
|Sponsor||Mauna Kea Technologies|
|Start date||February 2013|
|End date||October 2016|
|Trial size||200 participants|
|Trial identifier||NCT01793246, MKT_2012_lung_01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||St. Joseph's Medical Center||no longer recruiting|
|Jacksonville, FL||Mayo Clinic||no longer recruiting|
|Chicago, IL||University of Chicago||no longer recruiting|
|Columbus, IN||Columbus Regional Hospital||no longer recruiting|
|Shreveport, LA||University of Louisiana Shreveport||no longer recruiting|
|Bethesda, MD||Walter Reed Military Medical Center||no longer recruiting|
|Ann Arbor, MI||University of Michigan||no longer recruiting|
|Rochester, NY||University of Rochester||no longer recruiting|
|Columbus, OH||Ohio State University||no longer recruiting|
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
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.
Male or female participants at least 18 years old.
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
|Official title||Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs|
|Principal investigator||Cesar Keller, MD|
|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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