A Phase 1/2 interventional study of Near Infrared Imaging and Therapeutic Conventional Surgery in Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8 and Stage II Lip and Oral Cavity Cancer AJCC v8, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University of Washington · Phase 1/2, Interventional, and Diagnostic
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 8 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Near Infrared Imaging · Procedure: Therapeutic Conventional Surgery · Drug: Tozuleristide
Undergo NIR imaging
Also known as: Near-Infrared Imaging, NIR Imaging
Undergo surgery
Given IV
Also known as: BLZ-100
Number of Adverse Events (AEs)
Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.
Time frame: 7-21 days after drug administration
Number of Subjects Without Tumor Fluorescence After Receiving Tozuleristide
Number of subjects whose tumors did not show discernible fluorescence compared to background
Time frame: Measured at time of surgery 1 to 30 hours after receiving tozuleristide
Number of Participants for Which Negative Margins Were Achieved 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.
Time frame: Surgery performed following tozuleristide injection 1-30 hours prior to surgery
| Milestone | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.
| Event | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Acute hypoxemia, grade 3 | 1 |
| Aspiration pneumonia, grade 3 | 1 |
| Back wound, grade 3 | 1 |
| Constipation, grade 2 | 1 |
| Covid-19 infection, grade 3 | 1 |
| Fatigue, grade 3 | 2 |
| Ileus, grade 3 | 1 |
| Neck infection, grade 2 | 1 |
| Pulmonary embolism, grade 3 | 1 |
| Seroma, grade 2 | 1 |
Number of subjects whose tumors did not show discernible fluorescence compared to background
| Participants | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Number of Subjects Without Tumor Fluorescence After Receiving Tozuleristide | 4 |
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.
| Participants | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Number of Participants for Which Negative Margins Were Achieved in Tozuleristide-guided Oral Cavity Tumor Excision | 8 |
Collected over Time from administration of tozuleristide through the first postoperative follow-up visit occurring 7-21 days after study drug administration (End of Study Visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (Tozuleristide, Surgery, NIR Imaging) | 0/8 (0%) | 2/8 (25%) | 3/8 (37.5%) |
| Event | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| FatigueGeneral disorders | 2/8 |
| Acute hypoxemiaRespiratory, thoracic and mediastinal disorders | 1/8 |
| Aspiration pneumoniaRespiratory, thoracic and mediastinal disorders | 1/8 |
| Back woundMusculoskeletal and connective tissue disorders | 1/8 |
| Covid-19 infectionInfections and infestations | 1/8 |
| IleusGastrointestinal disorders | 1/8 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/8 |
| Event | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| ConstipationGastrointestinal disorders | 1/8 |
| Neck infectionInfections and infestations | 1/8 |
| SeromaBlood and lymphatic system disorders | 1/8 |
| Age, Continuous(years) | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Median | 60.5 (31 to 75) |
| Sex: Female, Male(Participants) | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Female | 4 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|
| Subsite(Participants) | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Oral tongue | 5 |
| Floor of mouth | 1 |
| Retromolar trigone | 1 |
| Buccal mucosa | 1 |
| Smoking(Participants) | Diagnostic (Tozuleristide, Surgery, NIR Imaging) |
|---|---|
| Current or former smokers | 6 |
| Never smokers | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Squamous Cell Carcinoma of Head and Neck→
University of Washington