This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Dose: 5 mg/kg IV injection prior to surgery
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States
RECRUITINGEstimates of sensitivity and specificity using ICG.
Sensitivity (specificity) will be estimated as the proportion of pathologically positive (negative) samples that do (do not) fluoresce using ICG.
Time frame: From time of surgery until final pathology results are available (about 2 weeks)
Frequency and proportion of samples for which visualization is altered using dimension.
The frequency and proportion of samples for which visualization is altered (normal vs abnormal) will be summarized in each dimension (anterior, posterior, left and right lateral, superficial, deep).
Time frame: From surgery until final pathology results are available (about 2 weeks)
Estimates of sensitivity and specificity using white light visualization.
Sensitivity and specificity point and interval estimates of white light visualization relative to pathology gold standard will be constructed as described for ICG.
Time frame: From surgery until final pathology results are available (about 2 weeks).
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