Near-Infrared Image Guided Surgical Resection with Indocyanine Green in Treating Patients with Head and Neck Cancer

Inclusion Criteria

• Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.
• Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
• Planned standard of care surgery with curative intent for squamous cell carcinoma.
• Have life expectancy of more than 12 weeks.
• Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1.
• Hemoglobin >= 9 gm/dL.
• White blood cell count > 3000/mm^3.
• Platelet count >= 100,000/mm^3.
• Serum creatinine =< 1.5 mg/dL.
• Liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin) =< 1.5 times the upper reference range.
• Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.
• Agree to not have radioactive iodine uptake studies done within 1 week of indocyanine green.

Exclusion Criteria

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Allergy to iodine or iodinated materials.
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.