Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Inclusion Criteria:

• Patient may be male or female and of any race / ethnicity
• Patient is > 18 years old at the time of investigational product administration
• Patient or patient's legally acceptable representative provides written informed consent
• Patient is capable of complying with study procedures
• Patient is capable of communicating with study personnel
• Patient must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx.
• According to the Karnofsky Performance Status Scale, the patient has a value of ≥ 60% at time of screening

• Patient must have normal organ and renal function as defined:

  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) less than or equal to 2.5 x institutional upper limits of normal
  • creatinine within normal institutional limits
  • BUN within normal institutional limits
  • PT and PTT < 2.0 x institutional upper limits of normal

Exclusion Criteria:

• Patient is younger than 18 years old at the time of investigational product administration
• Female patient is pregnant or has a positive serum pregnancy test
• Patient is unable to remain still for duration of imaging procedure
• Patient has a history of significant renal disease
• Patient has previously received [F-18]HX4 at any time, or any other investigational product in the past thirty days.
• Patient has been involved in an investigative, radioactive research procedure within the past year
• Inadequate tumor sites or volume to allow for biopsy
• Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete and good quality data