drugset / Trial / NCT05316688

A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery

NCT05316688 ↗

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

EvaluationDrugModalityDoseRoute
Subject tozuleristide Diagnostic / imaging agent — Intravenous