Feasibility Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

Eligibility Criteria

• * Minimum of 16 years of age.
• * Planning to undergo surgery in the Head and Neck.
• * Study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.
• * Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
• * Sexually active patients must be willing to use an acceptable method of contraception while participating in the study and for 30 days after receiving bevonescein.
• * Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study.
• * Patient has a history of prior surgery and/or radiation to the intended surgical site.
• * Patient has abnormal cardiac rhythm not controlled with medication.
• * Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) \< 60 mL/min.
• * Patient has decreased hepatic function defined as AST/SGOT and ALT/SGPT that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.
• * Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia, neuropathy \<= Grade 2, as well as other non-acute and stable anti-cancer therapy toxicities are acceptable.
• * Patient has a history of fluorescein allergy.
• * Patient has a history of drug-related anaphylactic or severe allergic reactions.
• * Presense or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the Investigator, places the patient at increased risk for adverse effects.
• * Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction, or cerebrovascular accident.
• * Presence or history of any condition, that in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
• * Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study.
• * Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.