Clinical trial · Interventional
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Why stopped (as posted): Terminated due to suboptimal delineation of fluorescence between tumor and native oral cavity mucosa.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage III Lip and Oral Cavity Cancer AJCC v8 | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Lip and Oral Cavity Cancer AJCC v8 | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Lip and Oral Cavity Cancer AJCC v8 | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Lip and Oral Cavity Cancer AJCC v8 | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Near Infrared Imaging | Procedure | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
| Tozuleristide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (tozuleristide, surgery, NIR imaging)
- description
- 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.
- interventionNames
- Procedure: Near Infrared Imaging
- Procedure: Therapeutic Conventional Surgery
- Drug: Tozuleristide
Primary outcomes (1)
- measure
- Number of Adverse Events (AEs)
- timeFrame
- 7-21 days after drug administration
- description
- Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects age \>= 18 years (yr) * 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: * Known or suspected sensitivity to indocyanine green * 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
References
Publications (0)
Data not yet available