OncoMatch/Clinical Trials/NCT05576974
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)
Is NCT05576974 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pegsitacianine for head and neck cancer.
Treatment: Pegsitacianine — This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage I, II, III, IV
Stage 1 to 4 HNSCC
Prior therapy
Cannot have received: investigational agent
Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing
Lab requirements
Blood counts
Acceptable hematologic status as standard surgery protocol requires, as determined by the Investigator
Kidney function
Acceptable kidney function as determined by the Investigator
Liver function
Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin >1.5× ULN must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor; Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis [excluded]
Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin >1.5× ULN must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor. Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Texas Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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