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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Lip Neoplasms
  • Mouth Neoplasms
  • Oral Cavity Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • 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

NCT number NCT05316688
Study type Interventional
Source University of Washington
Contact Rebecca Wood
Phone 206-606-6970
Email rwood1@fredhutch.org
Status Recruiting
Phase Phase 1/Phase 2
Start date May 4, 2024
Completion date January 20, 2027

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