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.
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.
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.
Adults with histologically or cytologically confirmed, or strong clinical suspicion of, head and neck squamous cell carcinoma who are preparing to undergo surgical resection at Washington University School of Medicine / Barnes-Jewish Hospital.
Cohort
Prospective
Indocyanine green
DrugClinical 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
Procedure/SurgeryContinuous video from completion of the saline flush (T0) through 3 minutes after each bolus, using an FDA-cleared ICG-compatible NIR imaging system.
Tumor-to-background ratio (TBR)
TBR is calculated as the mean fluorescence intensity (MFI) within a region of interest (ROI) drawn over pathology-confirmed tumor tissue divided by the MFI within an ROI drawn over adjacent clinically normal tissue, as measured on intraoperative near-infrared fluorescence imaging. The mean TBR with 95% confidence intervals will be reported.
Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection
Defined as the proportion of histopathologically confirmed tumor regions correctly identified as fluorescent. A standardized fluorescence ratio (SFR) threshold, determined by receiver operating characteristic (ROC) analysis using the maximum Youden's J index, will be used to classify tissue as fluorescent-positive or fluorescent-negative.
Specificity of Indocyanine Green (ICG) fluorescence for tumor detection
Defined as the proportion of histopathologically confirmed normal tissue regions correctly identified as non-fluorescent. A standardized fluorescence ratio (SFR) threshold, determined by receiver operating characteristic (ROC) analysis using the maximum Youden's J index, will be used to classify tissue as fluorescent-positive or fluorescent-negative.
Time to first detectable tumor fluorescence
Time in seconds from completion of the saline flush after intravenous ICG administration (T0) to the first visible tumor fluorescence above background on serial intraoperative NIR imaging.
Time to peak tumor-to-background ratio
Time in seconds from completion of the saline flush after intravenous ICG administration (T0) to the first visible tumor fluorescence above background on serial intraoperative NIR imaging.
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