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

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.

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