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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

StatusTerminated
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Sep 16, 2026 Primary endpoint revised · Eligibility criteria expanded, about 9 words · Secondary endpoints revised (2) · 1 more Show 4 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (2)
    • Site details revised
  2. Secondary endpoints: 6 to 2 Primary endpoint revisedv20 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Terminated Sponsor's reason: Terminated due to suboptimal delineation of fluorescence between tumor and native oral cavity mucosa. Enrollment target: estimated 15 to confirmed 8 · Primary completion date changed from estimate of Jan 20, 2026 to Sep 9, 2025 · Study completion date changed from estimate of Jan 20, 2027 to Sep 26, 2025 · 1 morev19 Show 4 more changesShow less
    • Enrollment target: estimated 15 to confirmed 8
    • Primary completion date changed from estimate of Jan 20, 2026 to Sep 9, 2025
    • Study completion date changed from estimate of Jan 20, 2027 to Sep 26, 2025
    • Site details revised
  4. 2 versions Re-verified since Nov 25, 2024, no change to tracked fieldsv17-v18
  5. Start date changed from estimate of May 4, 2024 to Apr 17, 2024 Site contact updatedv16 Show 1 more changeShow less
    • Site contact updated
Show 14 earlier versionsHide 14 earlier versions
  1. Start date: Apr 4, 2024 to May 4, 2024v15
  2. Start date: Feb 29, 2024 to Apr 4, 2024v14
  3. Start date: Jan 27, 2024 to Feb 29, 2024v13
  4. Start date: Dec 27, 2023 to Jan 27, 2024v12
  5. Trial status: Suspended to Recruiting Site details revisedv11 Show 1 more changeShow less
    • Site details revised
  6. Trial status: Recruiting to Suspended Sponsor's reason: Staffing Start date: Nov 12, 2023 to Dec 27, 2023 · Site details revisedv10 Show 2 more changesShow less
    • Start date: Nov 12, 2023 to Dec 27, 2023
    • Site details revised
  7. Trial status: Withdrawn to Recruiting Start date: Sep 23, 2023 to Nov 12, 2023 · Enrollment target: 0 to 15 · Site details revisedv9 Show 3 more changesShow less
    • Start date: Sep 23, 2023 to Nov 12, 2023
    • Enrollment target: 0 to 15
    • Site details revised
  8. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: Closed to accrual before enrolling any participants Enrollment target: estimated 15 to confirmed 0 · Eligibility criteria revised · Site contact updated · 1 morev8 Show 4 more changesShow less
    • Enrollment target: estimated 15 to confirmed 0
    • Eligibility criteria revised
    • Site contact updated
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  9. Start date: Sep 1, 2023 to Sep 23, 2023v7
  10. Start date: Jul 2, 2023 to Sep 1, 2023v6
  11. Start date: May 31, 2023 to Jul 2, 2023v5
  12. Start date: Mar 5, 2023 to May 31, 2023 Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
  13. Start date: Dec 2, 2022 to Mar 5, 2023v3
  14. Start date: Sep 1, 2022 to Dec 2, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05316688
Lead Sponsor University of Washington
Collaborators: Blaze Bioscience Inc.
Conditions 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
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov