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Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
Sponsor: Washington University School of Medicine
Summary
This observational study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy. ICG is a fluorescent dye given into a vein during surgery. Patients receive ICG as part of their clinical care, independently of whether they participate in this study. The study plans to enroll 25 adults undergoing surgery for confirmed or strongly suspected cancer. Researchers will record near-infrared images obtained during clinical ICG use, compare them with tissue pathology, and measure the strength, timing, and duration of fluorescence. The research analysis will not guide clinical or surgical decisions. Participants will be followed through 24 hours after surgery.
Official title: Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
25
Start Date
2026-09-30
Completion Date
2028-03-31
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Indocyanine green
Clinical exposure of interest: intraoperative ICG. The regimen described for observation is three 2 mg IV boluses, each followed by a saline flush, totaling 6 mg. Actual doses and times are recorded; clinical dosing is determined independently of study participation.
Near-infrared fluorescence imaging
Continuous video from completion of the saline flush (T0) through 3 minutes after each bolus, using an FDA-cleared ICG-compatible NIR imaging system.
Locations (1)
Washington University School of Medicine
St Louis, Missouri, United States