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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01734 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| FHIRB0020096 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to suboptimal delineation of fluorescence between tumor and native oral cavity mucosa.
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| Name | Class |
|---|---|
| Blaze Bioscience Inc. | INDUSTRY |
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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.
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 near infrared (NIR) imaging with standard of care device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (tozuleristide, surgery, NIR imaging) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Imaging | Procedure | Undergo NIR imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | 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. | 7-21 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects without tumor fluorescence after receiving tozuleristide | Up to 12 months | |
| Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Marchiano | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2025 | Feb 23, 2026 |
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| Therapeutic Conventional Surgery | Procedure | Undergo surgery |
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| Tozuleristide | Drug | Given IV |
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| Up to 12 months |
| Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies | 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. | Up to 12 months |
| 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 | 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. | Up to 12 months |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2026 |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000604732 | tozuleristide |
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