Status:
RECRUITING
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Blaze Bioscience Inc.
Conditions:
Oral Cavity Squamous Cell Carcinoma
Stage I Lip and Oral Cavity Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed 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) ima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05316688
Start Date
April 17 2024
End Date
January 20 2027
Last Update
June 11 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109