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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University of Washington

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Stage I Lip and Oral Cavity Cancer AJCC v8
Stage IVA Lip and Oral Cavity Cancer AJCC v8
Stage II Lip and Oral Cavity Cancer AJCC v8
Oral Cavity Squamous Cell Carcinoma
Stage III Lip and Oral Cavity Cancer AJCC v8

Treatments

Procedure: Near Infrared Imaging
Procedure: Therapeutic Conventional Surgery
Drug: Tozuleristide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05316688
RG1122110
NCI-2022-01734 (Registry Identifier)
FHIRB0020096 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Diagnostic (tozuleristide, surgery, NIR imaging)
Experimental group
Description:
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:
Drug: Tozuleristide
Procedure: Therapeutic Conventional Surgery
Procedure: Near Infrared Imaging

Trial contacts and locations

1

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Central trial contact

Emily Marchiano

Data sourced from clinicaltrials.gov

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