Glow-in-the-dark dye could save kidneys during surgery
NCT ID NCT07080008
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This early study tests if a dye called Lumitrace, given as a shot, can make the ureters (tubes from kidney to bladder) glow under a special blue light during minimally invasive belly surgery. About 10 adults having such surgery will get the dye, and surgeons will rate how well they can see the ureters compared to regular white light. The goal is to see if this method is safe and helps prevent accidental ureter injury.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery,
Kansas City, Missouri, 64108, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blue dye could help surgeons spot blocked ureters during operations
- New dye could help surgeons see and protect ureters during robotic colorectal surgery
- Glow-in-the-Dark dye could prevent surgical blunders
- Blue dye could make Children's surgery safer
- Blue dye could make surgery safer by spotting hidden ureter injuries