Actively Recruiting
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)
Led by University of Texas Southwestern Medical Center · Updated on 2026-04-14
120
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Biopsy-confirmed diagnosis or high clinical suspicion of primary or recurrent disease
- Part 1: Stage 1 to 4 head and neck squamous cell carcinoma (HNSCC)
- Part 2: Unknown primary cancer of the head and neck with metastatic disease to at least one cervical node and no biopsy-proven primary site
- Acceptable blood, kidney, and liver function as determined by the investigator
- Negative serum pregnancy test for women of childbearing potential
- Agree to use medically acceptable contraception during the study and for 6 months after if of childbearing potential
- Agree to abstain from alcohol from 72 hours before dosing through study day 10 (±48 hours)
- Adequate potential for follow-up
You will not qualify if you...
- Tumors in sites where intraoperative imaging is not feasible
- Life expectancy less than 12 weeks
- Karnofsky Performance Status below 70%
- Significant liver impairment or active liver disease
- Medical conditions preventing surgical resection as judged by the investigator
- Medical or psychiatric conditions preventing informed consent
- Pregnant or lactating women
- Use of medication with high risk of liver toxicity during the study
- Alcohol consumption within 72 hours before dosing
- Receipt of investigational agent within 5 half-lives or 30 days before dosing
- Inability to follow study assessment schedule
- Investigator's judgment that participation is not appropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
B
Baran Sumer, MD
CONTACT
S
Sindhu Voorugonda, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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