TumorGlow Intraoperative Molecular Imaging (IMI)

Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).

Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.

Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.

Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific). * Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer) * Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)

Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: * One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging, * One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging, * The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.