🏛️ Verified NIH Record • Updated 2026-04-09
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) (NCT05576974)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Texas Southwestern Medical Center
🩺 Plain-English Summary (8th-Grade Level)
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Who can join: Review the eligibility criteria below.
Location: University of Texas Southwestern Medical Center — Dallas, Texas
Age range: 18 Years to 99 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Texas Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 648-2904
Email: Baran.Sumer@UTSouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Head and Neck Cancer
- Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity — Boston, Massachusetts
- Imaging With a PET Agent for Detection of Cancers of the Head and Neck — New York, New York
- Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer — Miami, Florida
- ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy — Miami, Florida
- ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer — Bethesda, Maryland
- "QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer — Oklahoma City, Oklahoma
Explore by condition: All Head and Neck Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.