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

Summary

This phase I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery.

Eligibility

Inclusion 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

Exclusion Criteria:

* 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

Conditions6

Locations1 site

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