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

Inclusion Criteria:

• Adult subjects age >= 18 years (yr)

• Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamouscell carcinoma for which surgical excision is deemed clinically indicated by thetreating 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 ofcontraception from study enrollment through 30 days after receiving the studyproduct. Male subjects must agree to use 2 reliable methods of contraceptionsimultaneously for 30 days after receiving the study product if their partner is ofchild-bearing potential

• Available for all study visits and able to comply with all study requirements

Exclusion Criteria:

• Known or suspected sensitivity to indocyanine green

• In the opinion of the treating physician, subject has received photosensitizingmedication that could interfere or confound study results

• Any current medications with the potential to generate fluorescence or photochemicalreaction

• Enrolled in any other ongoing study

• Currently lactating or breastfeeding

• Positive pregnancy test or planning to become pregnant within 30 days (d) ofreceiving tozuleristide

• Any current condition, including psychological and social situations which, in theopinion of the investigator, would impact adversely on the subject or theinterpretation 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