Overview
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.
Description
- OUTLINE
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
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