Intraoperative Indocyanine Green Fluorescence Imaging for the Identification of Head and Neck Tumor Cells in Patients with a Mucosal Origin and at a High Risk of Recurrence

Inclusion Criteria

• Adult subjects at least 18 years of age
• Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence
• Good operative candidate as determined by the treating physician and/or multidisciplinary team
• Subject capable of giving informed consent and participating in the process of consent
• A woman of childbearing potential (WOCBP) must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge)

Exclusion Criteria

• Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
• A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless: * They are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or * They have had a hysterectomy
• Known allergy to iodides or shellfish
• Total bilirubin > 2 x institutional upper limit of normal (IULN). Participants with a history of Gilbert’s disease must have total bilirubin < 3mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) > 3 x IULN
• Currently incarcerated individuals