A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery

Eligibility Criteria

• * Adult subjects age \>= 18 years (yr)
• * Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery
• * Able to provide written informed consent
• * If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential
• * Available for all study visits and able to comply with all study requirements
• * Known or suspected sensitivity to indocyanine green
• * In the opinion of the treating physician, subject has received photosensitizing medication that could interfere or confound study results
• * Any current medications with the potential to generate fluorescence or photochemical reaction
• * Enrolled in any other ongoing study
• * Currently lactating or breastfeeding
• * Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide
• * Any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data
• * Creatinine clearance \< 60 mL/min
• * Aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN)
• * Alanine aminotransferase (ALT) \> 1.5 x ULN
• * Bilirubin \> 1.5 x ULN