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NCT05316688 | RECRUITING | Oral Cavity Squamous Cell Carcinoma

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

University of Washington

Brief 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.

Condition or disease

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

Intervention/treatment

Near Infrared Imaging

Therapeutic Conventional Surgery

Tozuleristide

Phase

PHASE1

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent
Actual Study Start Date : 2024-04-17
Estimated Primary Completion Date : 2026-01-20
Estimated Study Completion Date : 2027-01-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
Exclusion Criteria
  • * 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
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery

Location Details

NCT05316688

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Locations

RECRUITING

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109