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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent

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

Condition
Oral Cavity Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Seattle

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Emily Marchiano, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

2027-01-20