A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Canvas near infrared (NIR) imaging.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic (tozuleristide, surgery, NIR imaging) Beginning 1 hour before surgery, patients receive tozuleristide IV over 1-5 minutes. Patients then surgical resection per standard of care and undergo Canvas NIR imaging. |
Procedure: Near Infrared Imaging
Undergo NIR imaging
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Tozuleristide
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events (AEs) [7-21 days after drug administration]
Adverse events will be summarized as the number and percentage of patients with each type of adverse event, per Criteria for Adverse Events version 5.0.
Secondary Outcome Measures
- Number of subjects without tumor fluorescence after receiving tozuleristide [Up to 12 months]
- Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies [Up to 12 months]
Will be estimated by a repeated measure logistic regression modeling the probability of positive tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A general estimating equation (GEE) method will be used to estimate the regression parameters.
- Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies [Up to 12 months]
Will be estimated by a repeated measure logistic regression modeling the probability of negative tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A GEE method will be used to estimate the regression parameters. The repeated measures logistic regression will model the probability of tumor-negative biopsies.
- Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies [Up to 12 months]
- Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies [Up to 12 months]
- Achievement of negative margins in tozuleristide-guided oral cavity tumor excision [Up to 12 months]
To investigate the accuracy of tozuleristide fluorescent imaging in identifying tumor and achieving negative margins during excision of oral cavity squamous cell carcinoma and high-grade dysplasia.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients age >= 18 years (yr)
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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
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Able to provide written informed consent
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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
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Available for all study visits and able to comply with all study requirements
Exclusion Criteria:
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Known or suspected sensitivity to indocyanine green
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In the opinion of the treating physician, patient has received photosensitizing medication that could interfere or confound study results
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Any current medications with the potential to generate fluorescence or photochemical reaction
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Enrolled in any other ongoing study
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Currently lactating or breastfeeding
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Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide
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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
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Creatinine clearance < 60 mL/min
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Aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN)
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Alanine aminotransferase (ALT) > 1.5 x ULN
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Bilirubin > 1.5 x ULN
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- University of Washington
- Blaze Bioscience Inc.
Investigators
- Principal Investigator: Jeffrey Houlton, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1122110
- NCI-2022-01734