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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05316688
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Washington
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Emily Marchiano
Principal Investigator Affiliation Fred Hutch/University of Washington Cancer Consortium
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (tozuleristide, surgery, NIR imaging)

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.

Interventions

Procedure: - Near Infrared Imaging

Undergo NIR imaging

Procedure: - Therapeutic Conventional Surgery

Undergo surgery

Drug: - Tozuleristide

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Seattle, Washington

Status

Recruiting

Address

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Site Contact

Emily Marchiano

[email protected]

206-598-5000

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