Safety of PDT-Photofrin® Prior to Lung Surgery

Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have
the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic
technologies (such as navigational bronchoscopy) have been shown to enable physicians to
safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new
technology may now potentially offer bronchoscopic therapeutic interventions, such as
photodynamic therapy, to tumors that were previously unreachable due to their peripheral
anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is
activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits
no heat. This technique works to allow the medical doctor to specifically target and destroy
abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation
of the drug is done by lightning the abnormal area using a fiber optic device (very fine
fiber [like a fishing line] that permits light transmission) inserted into a flexible tube
with a light, called bronchoscope for the lung. The light activates the porfimer sodium
concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to assess the safety of using photodynamic therapy prior to
surgical resection of tumors located in the periphery of the lung.

Inclusion Criteria:

- Male or female aged 18-79

- Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung

- Candidate for surgical resection

- Candidate for bronchoscopy

Exclusion Criteria:

- Diagnostic of small cell lung cancer or carcinoid tumors

- Primary or metastatic lung tumor located in central lung or near vertebral body

- Tumor invades a major blood vessel

- Presence of concurrent non-solid malignancy

- Tumor previously treated with radiation therapy

- Chemotherapy in the last four weeks

- Tumor treated with PDT within the last 3 months

- Abnormal blood results