Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Washington
With
Blaze Bioscience Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
