Imaging and Biomarkers of Hypoxia in Solid Tumors
Imaging and Biomarkers of Hypoxia in Solid Tumors
Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human
 cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the
 tumor with oxygenated blood. It is currently understood that hypoxic tumors are more
 aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue
 biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to
 measure tumor hypoxia.
To establish PET imaging with the tracer EF5 as an accurate and reliable method for measuring
 the oxygen content of a tumor and to establish the measurement of secreted markers in blood
 as an accurate and reliable method for measuring the oxygen content of a tumor.
INCLUSION CRITERIA

 -  Any solid tumor malignancies of any stage meeting all of the following criteria:
 Minimum tumor dimension is at least 1 cm (to ensure it is above the detection
 threshold of PET imaging). Examples include but are not limited to: locally advanced
 squamous cell carcinoma of the head and neck to be treated by either initial surgery
 or primary chemoradiotherapy; inoperable non-small cell lung cancer or pancreatic
 carcinoma to be treated with stereotactic radiotherapy, which may be biopsied again at
 the time of percutaneous needle delivery of implanted fiducial markers.

 -  Patients with newly diagnosed malignancies should not have initiated treatment for
 their disease before participating in this study. Patients with recurrent or second
 malignancies may have had prior therapy as appropriate for their disease, but should
 have completed all prior treatment at least 30 days before participation in this study
 and should not have initiated new treatment for the current problem.

 -  Greater than or equal to eighteen years of age.

 -  Sufficiently healthy to tolerate all study procedures.

 -  Organ and marrow function sufficient to undergo planned therapy.

 -  Ability to understand and the willingness to sign a written informed consent document.

 EXCLUSION CRITERIA

 • Pregnant or nursing