Objectives and endpoints
ADVERSE EVENTS, URETER, SECONDARY
The primary objective was to select the dose of pudexacianinium for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery. The primary efficacy endpoint was successful anatomical visualization of the index ureter, defined as answering “yes” to the question “Can the ureter be adequately visualized with NIR-F?” at both 30 min after dosing and at the end of surgery. If the answer was “no” at either time point, visualization was deemed unsuccessful for that participant.Secondary objectives were to investigate the safety, tolerability, and PK of pudexacianinium; corresponding secondary endpoints included adverse events (AEs), 12-lead electrocardiogram data, pudexacianinium plasma concentrations, and urinary pudexacianinium concentration during surgery. Exploratory objectives were to investigate the relationship between the PK and pharmacodynamics of pudexacianinium, the fluorescence intensity of pudexacianinium, the duration of ureter visualization, and the benefit of visualization using pudexacianinium during surgery. Exploratory endpoints were visualization of the contralateral ureter when amenable to visualization and qualitative assessments (using a 4-point Likert scale) of fluorescence intensity and signal-to-background ratio.