Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Patients that have been diagnosed, or are suspected of having malignant pleural mesothelioma,
a cancer of the pleura, surgery may be considered as an attempt to treat the cancer. As part
of the testing needed before surgery, a pleuroscopy or video camera examination of the pleura
is necessary to establish the diagnosis and/or to evaluate the extent of the cancer. This
study evaluates the effects of cryotherapy (freezing spray) on the ability of a patient's
immune system to attack the cancer, as has been reported in other types of cancers. The
purpose of this research is to gather information on the safety and effectiveness of
cryotherapy in patients with malignant pleural mesothelioma. If successful, this study could
provide support for future studies evaluating this new treatment for mesothelioma.

Inclusion Criteria

- Subject provides informed consent

- Subject is >18 years of age

- Subject is deemed competent for making medical decisions

- Subject is scheduled to undergo pleuroscopy as part of their standard care for
pre-operative clinical staging of malignant pleural mesothelioma

- A negative pregnancy test is required in women of child-bearing potential, as standard
of care.

- Subject is mentally capable of understanding study procedures.

Exclusion Criteria

Study subject has any disease or condition that interferes with safe completion of the
study including:

- Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR)
> 1.5

- Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or
other novel anticoagulants have not been held for the standard time period published

- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120
beats/min, unless deemed to be stable with these values by the surgical or
interventional pulmonary attending physicians.

- Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial
blood (PaO2) < 60 on baseline oxygen requirements.

- Concurrent participation in another study involving investigational drugs or
investigational medical devices

- Absence of or limited access to the pleural space during medical pleuroscopy.

- Inability to read and understand the necessary study documents.