Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
Summary
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.
Arms & interventions
- DrugIndocyanine Green (ICG)
Dose: 5 mg/kg IV injection prior to surgery
Outcome measures
Primary
Estimates 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)
Secondary
Frequency and proportion of samples for which visualization is altered using dimension.
Time frame: From surgery until final pathology results are available (about 2 weeks)
Estimates of sensitivity and specificity using white light visualization.
Time frame: From surgery until final pathology results are available (about 2 weeks).
Eligibility criteria
Study locations (1)
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425