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Tests treatment safety and results for Head and Neck Cancer
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)
ClinicalTrials.gov ID: NCT05576974
What this study is testing
What is Pegsitacianine?
Pegsitacianine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Adults ≥18 years of age
- Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
- Part 1: Stage 1 to 4 HNSCC
- 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...
- Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function...
You likely can't join if
- Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
- Life expectancy \<12 weeks
- Karnofsky Performance Status \<70%
- Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis
- Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
See the full eligibility criteria
- Adults ≥18 years of age
- Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
- Part 1: Stage 1 to 4 HNSCC
- 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.
- Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate...
- Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women \<2 years after menopause)
- 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...
- 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.
- Adequate potential for follow up
- Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
- Life expectancy \<12 weeks
- Karnofsky Performance Status \<70%
- Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis
- Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Pregnant or lactating women
- 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
- Alcohol consumption within 72 hours before Pegsitacianine administration
- Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing
- Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study
- The PI considers that the patient should not participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.