The origin of regional failure in oral cavity squamous cell carcinoma with pathologically negative neck metastases.
Moran Amit, Tzu Chen Yen, Chun Ta Liao...
https://pubmed.ncbi.nlm.nih.gov/25074731Actively Recruiting
Phase 2
Age: 18Years - 99Years
All Genders
ID05576974
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
N/A
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
Researchers are evaluating Pegsitacianine, an intraoperative fluorescence imaging agent, in patients with head and neck cancers, including unknown primary cancer of the head and neck. This Phase 2a, open-label, non-randomized study aims to assess the safety and diagnostic performance of Pegsitacianine in imaging primary tumors and metastatic lymph nodes during routine surgical procedures. The study has two parts. Part 1 involves giving a single dose of 1 mg/kg Pegsitacianine 6 to 300 hours before surgery to patients with head and neck squamous cell carcinoma (HNSCC) to image their tumors. Part 2 uses the same dosing and timing to image tumors in patients with unknown primary cancer (UPC) of the head and neck undergoing examination under anesthesia with laryngoscopy and panendoscopy to identify the primary cancer site. If needed, alternate imaging schedules may be used. Participants will receive Pegsitacianine infusion before surgery, and their tumors will be imaged using the fluorescence agent. Researchers will monitor diagnostic performance and safety over five years. Assessments include imaging of primary tumors and metastatic lymph nodes, with additional data collected on HPV status. Follow-up will ensure participant safety and measure imaging effectiveness throughout the study period.
CONDITIONS
Brief 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
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Biopsy-confirmed diagnosis of primary or recurrent disease, or high clinical suspicion by Investigator
- Part 1: Stage 1 to 4 head and neck squamous cell carcinoma (HNSCC)
- Part 2: Unknown primary cancer (UPC) of the head and neck with metastatic disease to at least one cervical node and no biopsy-proven primary location
- Acceptable blood counts, kidney and liver function as determined by Investigator
- Negative serum pregnancy test for women of childbearing potential
- Agreement to use medically acceptable contraception during the trial and for 6 months after
- Agreement to abstain from alcohol from 72 hours before Pegsitacianine administration through Study Day 10
- Adequate potential for follow-up
You will not qualify if you...
- Tumors located where intraoperative imaging is not feasible
- Life expectancy less than 12 weeks
- Karnofsky Performance Status less than 70%
- Significant liver disease or hepatic impairment
- Lab values or conditions preventing surgical resection as judged by Principal Investigator
- Medical or psychiatric conditions preventing informed consent
- Pregnant or breastfeeding women
- Use of medications with high risk of liver toxicity during the study
- Alcohol consumption within 72 hours before Pegsitacianine administration
- Received investigational agents within 5 half-lives or 30 days before dosing
- Inability to adhere to study schedule or assessments
- Investigator's judgment that participation is not appropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 6 to 300 hours post dose
Participants receive a single dose of Pegsitacianine and undergo intraoperative fluorescence imaging during their routine surgery to detect primary tumors and metastatic lymph nodes.
1 imaging and surgery visit
Long-term Monitoring
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor diagnostic performance and safety of Pegsitacianine.
Periodic follow-up visits as determined by study team
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
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Research Team
B
Baran Sumer, MD
S
Sindhu Voorugonda, MBBS
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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