Study on Tozuleristide, a Fluorescent Tumor Marking Agent, for Imaging Oral Cavity Cancer and High-Grade Dysplasia During Surgery
Sponsor: University of Washington
ClinicalTrials ID:NCT05316688
This clinical trial is testing the safety of a new imaging agent, tozuleristide, which helps surgeons see cancerous cells more clearly during surgery for oral cavity cancer and high-grade dysplasia.
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Program Overview
This study is exploring the use of tozuleristide, a special imaging agent that binds to cancer cells in the mouth. When exposed to near-infrared light, tozuleristide makes the cancer cells light up, helping surgeons distinguish them from healthy cells during surgery. The trial aims to assess the safety of this approach in patients undergoing surgery for oral cavity squamous cell cancer or high-grade dysplasia.
Description
In this study, patients will receive an intravenous (IV) dose of tozuleristide about one hour before their surgery. The tozuleristide is given over a short period of 1 to 5 minutes. During the surgery, surgeons will use a near-infrared imaging device to help them see the cancer cells more clearly, thanks to the fluorescent effect of tozuleristide. This process is intended to improve the accuracy of the surgery by better identifying cancerous tissue.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Have suspected or confirmed oral cavity dysplasia or squamous cell carcinoma that requires surgical removal, as determined by the doctor.
- Able to provide written consent to participate in the study.
- If capable of having children, must agree to use two reliable forms of birth control during the study and for 30 days after receiving the study product. Men must also agree to use two forms of birth control if their partner can become pregnant.
- Available for all study visits and able to follow all study requirements.
Exclusion Criteria
- Known or suspected allergy to indocyanine green.
- Taking medications that could interfere with the study results, as judged by the doctor.
- Currently using medications that might cause fluorescence or a photochemical reaction.
- Participating in another ongoing study.
- Currently breastfeeding.
- Positive pregnancy test or planning to become pregnant within 30 days of receiving tozuleristide.
- Any condition, including psychological or social issues, that might negatively affect the participant or the study results, as judged by the investigator.
- Kidney function below a certain level (creatinine clearance less than 60 mL/min).
- Liver enzyme levels (AST or ALT) more than 1.5 times the normal upper limit.
- Bilirubin levels more than 1.5 times the normal upper limit.
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