Pilot Study to Evaluate Optical Frequency Domain Imaging for Diagnosis of Central Airway Disease

The prevalence and high mortality rate associated with lung squamous cell carcinoma and the
lack of any widely accepted screening and surveillance tools, highlights the need for new
imaging paradigms that will ultimately lead to a reduction in patient mortality.

Bronchial carcinoma-in-situ will progress to invasive cancer in over 40% of individuals, and
although the progression occurs over a long period of time, the majority of carcinomas are
detected in the later stages of disease development, offering patients only a slim chance of
cure. Although significant effort in the development of screening paradigms for the detection
of lung cancer in the central airways have been made, to date there is still no widely
accepted and validated approach. Optical frequency domain imaging (OFDI) is a recent
derivative of optical coherence tomography (OCT). OFDI can be used to conduct volumetric
microscopy of the airways at a resolution comparable with architectural histopathology. The
long term goal of this study is to use OFDI to screen the airways with the hope of detecting
squamous cell carcinoma at an early more curable stage.

Standard of care bronchoscopy preparation and procedures will be followed including moderate
sedation, pulse oximetry and blood pressure monitoring as per department protocol. A
combination of currently approved bronchoscopy techniques including standard white light
bronchoscopy, autofluorescence bronchoscopy, and narrow band imaging will be used to assess
the airways. Bronchial regions of interest (ROI) suspected to be premalignant or malignant,
will be imaged using the OFDI system and catheter prior to biopsy acquisition. It is
anticipated that a minimum of 3 OFDI-biopsy correlated pairs from each study participant will
be obtained. An additional OFDI and biopsy will be obtained from a normal ROI. It is expected
that the experimental procedure will add less than 10 minutes to the total length of the
bronchoscopy procedure, but a stopping rule will be instituted to ensure that the
experimental procedure does not exceed 20 minutes.

Inclusion Criteria:

- Patients undergoing bronchoscopy for known or suspected pulmonary malignancy in the
central airways

- Patients must be over the age of 18

- Patient must be able to give informed consent

- Women with child bearing potential must have a negative pregnancy test the day before
or the day of the procedure.

Exclusion Criteria:

- Patient does not meet the requirements to undergo clinical bronchoscopy, as determined by
the treating physician.