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

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

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