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NCT05316688 · ClinicalTrials.gov registry record · Phase 1
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery
A Phase 1 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05316688: Clinical Trial Phase 1 study, sponsored by University of Washington.
NCT05316688 is a Phase 1 study that was terminated before completion, run by University of Washington. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05316688, a Phase 1 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
Adverse events will be summarized as the number and percentage of patients with each type of adverse event, per Criteria for Adverse Events version 5.0.
Interventions
- PROCEDURE Therapeutic Conventional Surgery
- PROCEDURE Near Infrared Imaging
- DRUG Tozuleristide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 1 |
Why NCT05316688 stopped before completion
NCT05316688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Therapeutic Conventional Surgery is the first listed.
NCT05316688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05316688 about?
NCT05316688 is a clinical study titled "A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery". 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 c...
What is the current status of trial NCT05316688?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2024-04-17. Estimated completion is 2025-09-26.
What interventions are being tested in trial NCT05316688?
The interventions under investigation include: Therapeutic Conventional Surgery (PROCEDURE), Near Infrared Imaging (PROCEDURE), Tozuleristide (DRUG).
Who is sponsoring clinical trial NCT05316688?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05316688's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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