ICG with near-infrared imaging to visualize head and neck cancer during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, phase 2 study enrolling up to 25 adults undergoing surgical resection for head and neck squamous cell carcinoma. Patients receive indocyanine green (ICG) as part of their standard care, and researchers record intraoperative near-infrared fluorescence images to compare fluorescence with histopathology. The goal is to understand the timing, strength, and duration of ICG fluorescence and how well it corresponds to tumor boundaries, without using the imaging to guide clinical decisions. Imaging is captured from the start of ICG perfusion through 3 minutes after, while standard surgical procedures proceed independently of study participation. Follow-up is limited to 24 hours post-surgery for study purposes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed, or strong clinical suspicion contingent on standard of care pre-operative assessment, of head and neck squamous cell carcinoma (HNSCC), preparing to undergo surgical resection.
* At least 18 years of age.
* The effects of ICG on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to surgery and for 1 week after surgery. Should a woman become pregnant or suspect she is pregnant during this time or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG, sodium iodide, or other agents used in the study.
* Thyroid radioactive uptake study within 1 week of ICG administration.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day of surgery.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Bharat Panuganti, MD, FACS — Washington University School of Medicine
• Study coordinator: Bharat Panuganti, MD, FACS
• Email: bharatp@wustl.edu
• Phone: 314-362-7522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.