A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
NCT ID: NCT05316688
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2024-04-17
2027-01-20
Brief Summary
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Detailed Description
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Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (tozuleristide, surgery, NIR imaging)
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
Near Infrared Imaging
Undergo NIR imaging
Therapeutic Conventional Surgery
Undergo surgery
Tozuleristide
Given IV
Interventions
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Near Infrared Imaging
Undergo NIR imaging
Therapeutic Conventional Surgery
Undergo surgery
Tozuleristide
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Blaze Bioscience Inc.
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Emily Marchiano
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2022-01734
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020096
Identifier Type: OTHER
Identifier Source: secondary_id
RG1122110
Identifier Type: -
Identifier Source: org_study_id
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