Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery

Exclusion Criteria20

• For Phase 2, the procedure must require identification of one or both ureters using dissection, mobilization, or other surgical means.
• The planned surgical procedure is open or minimally invasive surgery (MIS), including robotic.
• Both ureters are expected to be present and functional.
• Capable and willing to provide informed consent prior to study-specific procedures
• Screening laboratory test results are within normal limits, or if any are outside of normal limits, they are considered by the site PI, and confirmed by the lead PI, to be clinically insignificant.
• Negative pregnancy test in women of childbearing potential
• Known cardiovascular or pulmonary disease, renal or liver dysfunction, immunological disease, diabetes, or active cancer that would render the study subject unfit for surgery
• The planned surgical procedure is renal transplant or nephrectomy \[note: partial nephrectomy is permitted provided that estimated glomerular filtration rate (eGFR) is not expected to fall below normal age-based limits\]
• Prior renal transplant
• Impaired renal function defined as an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2
• Impaired liver function defined as values > 1.5 times the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin, or < lower limit of normal (LLN) for albumin
• Coagulopathy as manifested by international normalized ration (INR) > 1.3 (unless patient is on anti-coagulants)
• Subjects with a marked baseline prolongation of QT/ corrected QT interval (QTc) interval (e.g., a QTc interval > 480 msec \[CTCAE grade 1\] using Fridericia's QT correction factor (14)
• History of a clinically significant allergy or anaphylaxis to a component of the investigational medicinal product (IMP)
• Known sensitivity to fluorescent light
• Alcohol or recreational drug use that meets diagnostic and statistical manual of mental disorders (DSM5) criteria for moderate or severe substance use disorder
• Pregnant or breastfeeding, or lack of effective contraception for at least one week post-surgery in male or female subjects with reproductive potential: for males, condom use; for females, oral contraceptives, diaphragm, or intrauterine devices (IUDs)
• Any condition that the investigator considers to be potentially jeopardizing to the study subject's well-being or the study's objectives.
• Participated in an interventional clinical research study within the previous 30 days.
• The planned use of an 800 nm NIR fluorophore that is not Nizaracianine (e.g., indocyanine green or Pafolacianine) immediately before, during, or immediately after the planned abdominopelvic procedure.