Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries

Inclusion criteria

• Age > 18 years - male or female

• Eligible female non-pregnant subjects who are either not of child-bearing potential or willing to use adequate contraception during the trial
• Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration
• For women of child-bearing potential, the subject should have a negative serum pregnancy test on day of surgery, and agrees to one of the following acceptable contraceptive methods used consistently and correctly from the time of consent through 30 days after Lumitrace administration; i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system, or male partner sterilization
• Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace
• Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
• Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification
• eGFR≥60 mL/min/1.73m2

Exclusion criteria

• Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability to complete study requirements or may put the subject at increased risk, or compromise the interpretability of study results, which makes the participant unsuitable for study participation
• Participant is anticipated to require ureteral stenting during surgery
• Participant has an active urinary tract infection requiring antibiotic therapy
• Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance
• Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI
• Participant with body weight < 30 kilogram (kg)
• History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy)
• Participant has received any investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening
• eGFR <60 mL/min/1.73m2
• Participants with positive serum pregnancy test