Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
This phase Ib/II trial studies the side effects of near-infrared image guided surgical
 resection with indocyanine green in treating patients with head and neck cancer.
 Near-infrared image guided surgical resection with indocyanine green may make it easier to
 find and remove tumors.
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.