NCT05316688

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Oral Cavity Squamous Cell Carcinoma
• Stage I Lip and Oral Cavity Cancer AJCC v8
• Stage II Lip and Oral Cavity Cancer AJCC v8
• Stage III Lip and Oral Cavity Cancer AJCC v8
• Stage IVA Lip and Oral Cavity Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Near Infrared Imaging	Undergo NIR imaging
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery
DRUG	Tozuleristide	Given IV

Timeline

• Start date: 2024-04-17
• Primary completion: 2025-09-09
• Completion: 2025-09-26
• First posted: 2022-04-07
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study