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

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