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NCT05576974 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)
A Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05576974 is a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 120 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05576974, a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Conditions Studied
Interventions
- DRUG Pegsitacianine
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05576974
The ClinicalTrials.gov registry entry for NCT05576974 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (54% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pegsitacianine is the first listed.
NCT05576974 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05576974 about?
NCT05576974 is a clinical study titled "A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)". This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
What is the current status of trial NCT05576974?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-04-17. Estimated completion is 2027-12-31.
What conditions does trial NCT05576974 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Unknown Primary Cancer.
What interventions are being tested in trial NCT05576974?
The interventions under investigation include: Pegsitacianine (DRUG).
Who is sponsoring clinical trial NCT05576974?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05576974 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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