Imaging and Biomarkers of Hypoxia in Solid Tumors

Inclusion Criteria:

3.1.1 Eligible Diseases

Any solid tumor malignancies of any stage meeting all of the following criteria: 1. Tumor
is accessible for minimally invasive biopsy (i.e., not requiring general anesthesia; e.g.,
FNA, core needle, punch, excision under local anesthesia) OR surgical resection is the
planned initial treatment regardless of participation in this study; 2. 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.

In addition, a subset of patients will be eligible for the carbogen breathing portion of
the study if their initial 18F-EF5 scan demonstrates increased tumor uptake (tumor:blood
ratio > 1.5).

3.1.2 Allowable type and amount of prior therapy: 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.

3.1.4 Patients must be greater than or equal to eighteen years of age.

3.1.5 ECOG or Karnofsky Performance Status will not be employed, but patients will need to
be sufficiently healthy to tolerate all study procedures.

3.1.6 Requirements for organ and marrow function are not applicable to this study, but
function will need to be sufficient to undergo planned therapy.

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

Exclusion Criteria:Pregnant or nursing patients will be excluded from the study.