RECRUITING

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

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Conditions

Oral Cavity Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-17
Study Completion:2027-01-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05316688

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult subjects age \>= 18 years (yr)
  2. * 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
  3. * Able to provide written informed consent
  4. * 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
  5. * Available for all study visits and able to comply with all study requirements
  1. * Known or suspected sensitivity to indocyanine green
  2. * In the opinion of the treating physician, subject has received photosensitizing medication that could interfere or confound study results
  3. * Any current medications with the potential to generate fluorescence or photochemical reaction
  4. * Enrolled in any other ongoing study
  5. * Currently lactating or breastfeeding
  6. * Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide
  7. * 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
  8. * Creatinine clearance \< 60 mL/min
  9. * Aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN)
  10. * Alanine aminotransferase (ALT) \> 1.5 x ULN
  11. * Bilirubin \> 1.5 x ULN

Contacts and Locations

Study Contact

Emily Marchiano
CONTACT
206-598-5000
ejm1014@uw.edu

Principal Investigator

Emily Marchiano
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Washington

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-17
Study Completion Date2027-01-20

Study Record Updates

Study Start Date2024-04-17
Study Completion Date2027-01-20

Terms related to this study

Additional Relevant MeSH Terms

  • 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