Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries

Launched by MEDIBEACON · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help surgeons see the ureters—tubes that carry urine from the kidneys to the bladder—during certain types of minimally invasive abdominal and pelvic surgeries. The researchers want to find out if a special dye called Lumitrace, used together with a special blue light system, can make the ureters easier to see during surgery. This could help prevent accidental injury to these important tubes. The study also aims to check if a single dose of Lumitrace is safe and well-tolerated in patients.

Adults scheduled for laparoscopic (keyhole) surgery in the abdomen or pelvis might be eligible to join, as long as they are over 18, have good kidney function, and are not pregnant. Women must not be pregnant and must agree to use contraception if of childbearing age, and men must also agree to use birth control or abstain for a period after receiving the dye. Participants will receive one injection of Lumitrace before surgery, and during the operation, the surgeon will use a special light system to see the ureters and rate how well they are visible. There will be a safety check-up about two weeks after the surgery to make sure everything is okay. This study will include up to 10 participants and is not yet recruiting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years - male or female
• • 1. Eligible female non-pregnant subjects who are either not of child-bearing potential or willing to use adequate contraception during the trial
• • 2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration
• • 3. 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
• • 4. Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace
• • 2. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
• • 3. Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification
• • 4. eGFR≥60 mL/min/1.73m2
• Exclusion Criteria:
• • 1. 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
• • 2. Participant is anticipated to require ureteral stenting during surgery
• • 3. Participant has an active urinary tract infection requiring antibiotic therapy
• • 4. 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
• • 5. Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI
• • 6. Participant with body weight \< 30 kilogram (kg)
• • 7. 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)
• • 8. Participant has received any investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening
• • 9. eGFR \<60 mL/min/1.73m2
• • 10. Participants with positive serum pregnancy test