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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs

Conditions
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Lung Neoplasms, Disorder Related to Lung Transplantation

Intervention / Treatment
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* Device: probe based laser endomicroscopy (pCLE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pCLE for Discrete lung lesions<br>Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy | Device: probe based laser endomicroscopy (pCLE)<br>* pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.<br>* Other names: optical endomicroscopy;|
| pCLE for acute lung transplant rejection<br>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)<br>* pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.<br>* Other names: optical endomicroscopy;|

What is the study measuring?
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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. | 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. | For Group 2 - Transplant rejection | Up to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, lung neoplasms, lung transplant