Tozuleristide Imaging Agent for Oral Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot take any medications that could cause fluorescence or a photochemical reaction, as these could interfere with the study results.
How does the drug Tozuleristide differ from other treatments for oral cancer?
Tozuleristide is unique because it is a near-infrared fluorescence (NIRF) imaging agent that helps surgeons visualize oral cancer during surgery, potentially improving the precision of tumor removal. This is different from standard treatments that do not typically involve real-time imaging to guide surgical procedures.12345
What data supports the effectiveness of the drug Tozuleristide for oral cancer?
Research shows that chlorotoxin, a component of Tozuleristide, has been effective in targeting and imaging brain tumors, suggesting its potential to help visualize tumors during surgery. Additionally, indocyanine green, another component, has been used in imaging for head and neck cancers, indicating its usefulness in detecting cancerous tissues.14567
Who Is on the Research Team?
Emily Marchiano
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults over 18 with suspected or confirmed oral cavity dysplasia or early to advanced squamous cell carcinoma needing surgery. Participants must be able to follow the study plan and use two reliable contraception methods if of child-bearing potential. Excluded are those on certain medications, pregnant or breastfeeding women, and individuals with specific sensitivities or abnormal blood tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tozuleristide intravenously 1 hour before surgery, followed by surgical resection and near infrared imaging
Follow-up
Participants are monitored for adverse events and the effectiveness of tumor excision
Long-term follow-up
Participants are monitored for the accuracy of tozuleristide imaging in achieving negative margins and detecting tumors
What Are the Treatments Tested in This Trial?
Interventions
- Tozuleristide
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Blaze Bioscience Inc.
Industry Sponsor