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)
| NCT ID | NCT05576974 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-04-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥18 years of age 2. Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator) 1. Part 1: Stage 1 to 4 HNSCC 2. Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location. 3. 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× the upper limit of normal \[ULN\] must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor. 4. Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause) 5. Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter 6. Agree to abstain from alcohol consumption from 72 hours before Pegsitacianine administration through completion of Study Day 10 (±48 hours) visit in Part 1 and Part 2. 7. Adequate potential for follow up Exclusion Criteria: 1. Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible. 2. Life expectancy \<12 weeks 3. Karnofsky Performance Status \<70% 4. Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis 5. Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection 6. Medical or psychiatric conditions that compromise the patient's ability to give informed consent. 7. Pregnant or lactating women 8. Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center 9. Alcohol consumption within 72 hours before Pegsitacianine administration 10. Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing 11. Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study 12. The PI considers that the patient should not participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05576974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05576974 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05576974 currently recruiting?
Yes, NCT05576974 is actively recruiting participants. Contact the research team at Baran.Sumer@UTSouthwestern.edu for enrollment information.
Where is the NCT05576974 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT05576974 clinical trial?
NCT05576974 is sponsored by University of Texas Southwestern Medical Center. The trial plans to enroll 120 participants.
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