RecruitingPhase 2NCT05576974
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)
Sponsor
University of Texas Southwestern Medical Center
Enrollment
120 participants
Start Date
Apr 17, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Plain Language Summary
Simplified for easier understanding
This study is evaluating a new fluorescent imaging agent called pegsitacianine that surgeons can use during operations to better identify cancer tissue in real time. It is being tested in patients with head and neck cancer, including those with an unknown primary cancer site.
**You may be eligible if...**
- You are 18 or older
- You have been diagnosed (or there is high clinical suspicion) of head and neck squamous cell carcinoma (HNSCC), stage 1–4
- OR you have a type of head and neck cancer where the primary tumor location is unknown, but cancer has spread to a lymph node in the neck
- Your blood, kidney, and liver function are acceptable for surgery
**You may NOT be eligible if...**
- You have known allergies to the imaging agent
- Your organ function does not meet surgical safety requirements
- You cannot undergo surgery for other medical reasons
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGPegsitacianine
Infusion of the Pegsitacianine-Intraoperative fluorescence imaging
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05576974
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