Evaluating a new imaging agent for detecting head and neck cancer

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)

This study is testing a new imaging agent to see if it can help doctors find head and neck cancers more easily during surgery, especially in patients with known or unknown cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT05576974 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and diagnostic performance of Pegsitacianine, an intraoperative fluorescence imaging agent, in patients with head and neck cancers, including those with unknown primary cancer. It is a non-randomized, open-label, single-center study where participants will receive a single dose of Pegsitacianine prior to surgery. The imaging will occur between 6 to 300 hours post-administration to assess the agent's effectiveness in visualizing tumors during routine surgical procedures. The study is divided into two parts, focusing on patients with known head and neck squamous cell carcinoma and those with unknown primary cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with biopsy-confirmed head and neck squamous cell carcinoma or unknown primary cancer with metastatic disease.

Not a fit: Patients without a confirmed diagnosis of head and neck cancer or those with significant comorbidities affecting surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to detect and visualize head and neck cancers during surgery, potentially leading to better surgical outcomes.

How similar studies have performed: Other studies have shown promise with similar imaging agents, but this specific application of Pegsitacianine is novel.

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

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Baran Sumer, MD

Conditions Head and Neck Cancer; Unknown Primary Cancer; Head and Neck Squamous Cell Carcinoma