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

PRIMARY OBJECTIVES:

I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and
neck cancer surgical patients.

SECONDARY OBJECTIVES:

I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to
surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer
resections.

OUTLINE:

Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared
image guided surgical resection on day 1.

After completion of study treatment, patients are followed up for 14-30 days.

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.