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

NCT05316688 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-02-25

No results posted yet for this study

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.

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

PROCEDURE

Near Infrared Imaging

Undergo NIR imaging

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

DRUG

Tozuleristide

Given IV

Sponsors & Collaborators

Principal Investigators

  • Emily Marchiano · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2025-09-09
Completion
2025-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05316688 on ClinicalTrials.gov