Lumitrace with KARL STORZ blue-light imaging to highlight ureters during abdominopelvic surgery
A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light (WL) Fluorescence (BLUE) in Participants Undergoing Minimally Invasive Abdominopelvic Surgeries
This trial will test whether a single IV dose of Lumitrace used with the KARL STORZ POWER LED BLUE System helps surgeons see the ureters during laparoscopic abdominopelvic surgery in adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MediBeacon Industry-sponsored |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT07080008 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-center interventional study will enroll up to 10 adults undergoing laparoscopic abdominopelvic surgery to receive a single 130 mg intravenous dose of Lumitrace. Within 30 minutes of injection, ureter visualization will be documented using the KARL STORZ POWER LED BLUE System with both white light and fluorescence imaging. The study will record feasibility measures of intraoperative ureter visualization and collect safety and tolerability data. Participants will have a screening visit within 28 days prior to dosing and will be monitored for adverse events according to protocol.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for laparoscopic abdominopelvic surgery who are non-pregnant (or agree to specified contraception) and willing to receive a single IV dose of Lumitrace would be appropriate candidates.
Not a fit: People who are pregnant, not having laparoscopic abdominopelvic surgery, or unable/unwilling to receive an IV dye or follow contraception requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help surgeons avoid accidental ureter injuries by making the ureters easier to see during surgery.
How similar studies have performed: Fluorescent ureter visualization has been explored in prior feasibility studies with other dyes, but use of Lumitrace with this specific blue-light system is an early and relatively novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Missouri
- University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery, — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Richard B Doshow, PhD
- Email: rbdorshow@medibeacon.com
- Phone: 314-735-0967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.