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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE)
Study Overview
Brief Summary
The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.
The main questions it aims to answer are:
- To evaluate the feasibility and clinical utility of Lumitrace to provide ureter visualization when used in tandem with the KARL STORZ POWER LED BLUE System during laparoscopic abdominopelvic surgery
- To evaluate the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing laparoscopic abdominopelvic surgery
Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.
Up to 10 participants will be enrolled and will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.
A safety follow-up visit will occur within 14 ±7 days of Lumitrace administration.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
130 mg Lumitrace
Participants will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.
Intervention: Lumitrace (Drug)
130 mg Lumitrace
Participants will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.
Intervention: KARL STORZ POWER LED BLUE System (Device)
Outcomes
Primary Outcomes
Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE)
Time Frame: Day of surgery
Imaging will be acquired within 30 minutes post Lumitrace administration. Images from one or both ureters may be evaluated for anatomical visualization. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on the Likert Scales as follows. White light visibility will be measured using a 4-point scale where 0 represents not visible and 3 represents excellent visibility. For images collected using the BLUE setting, intensity will be graded based on the following: (0 = none; 1 = mild; 2 = moderate; and 3 = strong).
Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE)
Time Frame: Day of surgery
Imaging will be acquired within 30 minutes post Lumitrace administration. Images from one or both ureters may be evaluated for anatomical visualization. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on the Likert Scales as follows. White light visibility will be measured using a 4-point scale where 0 represents not visible and 3 represents excellent visibility. For images collected using the BLUE setting, intensity will be graded based on the following: (0 = none; 1 = mild; 2 = moderate; and 3 = strong).
Secondary Outcomes
No secondary outcomes reported