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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: Recruiting Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours) post dose. All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±24 hours). All patients will be mo
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 |
What NCT05576974 shows while recruiting
NCT05576974 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (54% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05576974's enrollment target sits among peer trials
120 73rd of 250 higher than 177 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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