Using a fluorescent agent to improve surgery for oral cavity cancer
Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent
This study is testing a special dye to see if it helps surgeons better see and remove cancer in the mouth during surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05316688 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial investigates the use of tozuleristide, a fluorescent tumor marking agent, to enhance the imaging of oral cavity squamous cell carcinoma and high-grade dysplasia during surgical procedures. Patients will receive tozuleristide intravenously shortly before surgery, allowing surgeons to visualize tumor cells more clearly under near-infrared light. The goal is to improve surgical outcomes by helping surgeons distinguish between cancerous and healthy tissue more effectively. The study aims to assess both the safety and efficacy of this imaging approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or confirmed oral cavity dysplasia or squamous cell carcinoma requiring surgical excision.
Not a fit: Patients with known sensitivity to indocyanine green or those on photosensitizing medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical removal of tumors, potentially improving patient outcomes and reducing recurrence rates.
How similar studies have performed: Other studies using fluorescent imaging agents in cancer surgery have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Emily Marchiano — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Emily Marchiano
- Email: ejm1014@uw.edu
- Phone: 206-598-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.