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Tozuleristide Imaging Agent for Oral Cancer

Phase 1 & 2

Recruiting

Led By Jeffrey Houlton

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is testing a new imaging agent that could help surgeons better distinguish cancerous from healthy cells during surgery to remove oral cavity tumors.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed oral cavity dysplasia or early to advanced squamous cell carcinoma needing surgery. Participants must be able to follow the study plan and use two reliable contraception methods if of child-bearing potential. Excluded are those on certain medications, pregnant or breastfeeding women, and individuals with specific sensitivities or abnormal blood tests.Check my eligibility

What is being tested?

The trial is testing Tozuleristide, a fluorescent marker that binds to tumor cells making them glow under near-infrared light during surgery. This helps surgeons see and remove cancerous tissue more accurately compared to healthy tissue.See study design

What are the potential side effects?

Potential side effects may include reactions related to the imaging agent Tozuleristide such as sensitivity issues due to its fluorescence properties. The exact side effects aren't detailed but could relate to the compound's interaction with light during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am suspected or confirmed to have early-stage mouth cancer needing surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

Secondary outcome measures

Achievement of negative margins in tozuleristide-guided oral cavity tumor excision

Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies

Number of subjects without tumor fluorescence after receiving tozuleristide

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (tozuleristide, surgery, NIR imaging)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Near Infrared Imaging

2013

Completed Phase 1

~10

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,923 Total Patients Enrolled

Blaze Bioscience Inc.Industry Sponsor

7 Previous Clinical Trials

233 Total Patients Enrolled

Jeffrey HoultonPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Media Library

Tozuleristide Clinical Trial Eligibility Overview. Trial Name: NCT05316688 — Phase 1 & 2

Lip and Oral Cavity Cancer Research Study Groups: Diagnostic (tozuleristide, surgery, NIR imaging)

Lip and Oral Cavity Cancer Clinical Trial 2023: Tozuleristide Highlights & Side Effects. Trial Name: NCT05316688 — Phase 1 & 2

Tozuleristide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316688 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies in this trial for willing participants?

"Unfortunately, this specific trial is not looking for new participants at the moment. The original posting was on December 2nd, 2022 and there have been no updates since September of that same year. There are however, 2802 other trials currently underway that may be seeking patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05316688.