Pudexacianinium chloride (ASP5354) for ureter visualization in patients undergoing abdominopelvic surgery: a phase III, multicenter, open-label, randomized study

Abstract Background This phase III, multicenter, randomized, open-label study (NCT05754333) evaluated pudexacianinium chloride (ASP5354), a novel near-infrared fluorescence (NIR-F) imaging agent, for intraoperative ureter identification in minimally invasive and open abdominopelvic surgeries. Methods Patients with normal renal function, mild renal impairment, or patients with moderately impaired renal function received one intravenous dose of pudexacianinium 3 mg intraoperatively. Investigators scored ureter conspicuity under white light (WL) or (WL+)NIR-F using a validated 5-point Likert scale. Primary and key secondary endpoints included intra-participant differences in conspicuity scores for WL versus (WL+)NIR-F, supported by blinded central image review and quantitative contrast enhancement factor (CEF) analysis. Results Adults with normal renal function or mild renal impairment were randomly assigned in a 5:1 ratio to WL+NIR-F arm (intent-to-treat population, n = 72 [median age 55.0 years; 68.1% female]) or to WL-only arm ( n = 13 [median age 64.0 years; 76.9% female]). Eight adults with moderate renal impairment (median age 70.0 years; 75.0% female) and 14 adolescents with normal renal function or mild renal impairment (median age 14.5 years; 57.1% female) were imaged under WL+NIR-F (no randomization). In the same participants of intent-to-treat population, (WL+)NIR-F yielded significantly higher conspicuity scores than WL, both 30 min (± 15) postdose and at end of surgery, confirmed by central review and CEF analysis. Benefits persisted to 210 min post-injection (timepoints with ≥ 5 evaluable patients). No drug-related serious adverse events occurred, and most treatment-emergent adverse events were mild- or moderate-grade. Adults with moderate renal impairment had higher mean plasma pudexacianinium concentrations and slower urinary excretion than adults with normal renal function or mild renal impairment. Adolescents had numerically lower mean urine production rates and higher mean urine pudexacianinium concentrations than adults. Conclusions Pudexacianinium is an effective visualization agent without invasive instrumentation. NIR-F imaging with pudexacianinium enhances ureter identification compared with WL-only, which may reduce risk of intraoperative ureter injury.