drugset / Trial / NCT05316688
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2024-04-17
- Primary completion
- 2025-09-09
- Completion
- 2025-09-26
Outcome
Outcome not reported
Stopped: “Terminated due to suboptimal delineation of fluorescence between tumor and native oral cavity mucosa.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tozuleristide | Diagnostic / imaging agent | — | Intravenous |