A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
Stopped early · Phase 1/Phase 2
Conditions studied: Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8
In brief
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.
Key facts
- Study ID
- NCT05316688
- Run by
- University of Washington
- People needed
- 8
- Starts
- 2024-04-17
- Expected to finish
- 2025-09-26
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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