Lumitrace for Ureteral Injury

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MediBeacon

Disqualifiers: Cardiac disease, UTI, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Lumitrace, a new medicine, to determine if it helps doctors see the ureters (tubes from the kidneys to the bladder) during certain surgeries. The trial also aims to assess whether a special light system can enhance this visualization and to evaluate Lumitrace's safety for patients. Participants scheduled for minimally invasive abdominal or pelvic surgery, where locating the ureters is necessary, might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how Lumitrace works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that Lumitrace and the KARL STORZ POWER LED BLUE System are safe for ureter visualization?

Researchers are testing Lumitrace to determine if it can help doctors see the ureters (the tubes that carry urine from the kidneys to the bladder) more clearly during certain surgeries. This clarity is crucial to prevent injury during operations. The trial involves a small group of participants who receive a single dose of Lumitrace through an IV, administered directly into a vein.

As this is an early study, limited information exists on how people react to Lumitrace. Early-phase studies typically focus on safety and identifying any side effects. Participants are closely monitored after receiving the treatment to quickly identify and manage any potential side effects.

Since this is the initial phase of testing, further studies will be necessary to confirm Lumitrace's safety and effectiveness. If Lumitrace is already safe for another condition, it might generally be well-tolerated, but certainty is premature. Participants in the trial will help determine its true safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for ureteral injury, which usually involves surgical repair or stenting, Lumitrace offers a novel approach by enhancing visualization during surgery. Researchers are excited about Lumitrace because it uses a unique fluorescence mechanism that improves the surgeon's ability to see the ureter with greater clarity and precision. This enhanced visualization could potentially lead to more accurate and safer surgical procedures, reducing the risk of complications. Additionally, Lumitrace is administered as a single intravenous dose, simplifying the treatment process compared to more invasive options.

What evidence suggests that Lumitrace and the KARL STORZ POWER LED BLUE System are effective for ureter visualization?

Research has shown that Lumitrace, when used with the KARL STORZ POWER LED BLUE System, helps surgeons see the ureters more clearly during surgery. This trial will evaluate the effectiveness of a single intravenous 130 mg dose of Lumitrace in enhancing ureter visualization. This combination aims to improve safety by making the ureters easier to see, reducing the risk of accidental injury. Lumitrace possesses special glowing properties that highlight the ureters under a specific light, increasing their visibility to surgeons. Although Lumitrace is primarily used to check kidney function, its ability to enhance the visibility of internal structures shows promise for surgeries. Early studies suggest that this method could provide clearer images without invasive procedures. ^{1 2 5 6 7}

Who Is on the Research Team?

Richard B Dorshow, PhD

Principal Investigator

MediBeacon, Inc.

Are You a Good Fit for This Trial?

This trial is for up to 10 people who need laparoscopic abdominopelvic surgery and are at risk of ureteral injury. Participants must be screened within 28 days before receiving Lumitrace and agree to a follow-up visit after the procedure.

Inclusion Criteria

I am not pregnant and will use birth control during the trial.

I am scheduled for a surgery that involves a camera to look inside my belly and may need to identify tubes connecting my kidneys and bladder.

I can understand and agree to the study's requirements.

Exclusion Criteria

Participants with positive serum pregnancy test

My body weight is less than 30 kg.

Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive a single intravenous 130 mg dose of Lumitrace, and ureter visualization is captured using the KARL STORZ POWER LED BLUE System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lumitrace

Trial Overview The study tests if Lumitrace, given through an IV, helps surgeons see the ureters better during surgery using the KARL STORZ LED system. Surgeons will use white light and fluorescence to rate how well they can see the ureters.

How Is the Trial Designed?

Group I: 130 mg Lumitrace Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

MediBeacon

Lead Sponsor

Trials

9

Recruited

830+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07080008

Evaluation of Lumitrace for Visualizing Ureters During ... 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 ...

2. withpower.com withpower.com/trial/phase-1-ureteral-injury-7-2025-5c97f

Lumitrace for Ureteral Injury · Info for Participants This trial is for up to 10 people who need laparoscopic abdominopelvic surgery and are at risk of ureteral injury. Participants must be screened within 28 days ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39266754/

Utility and challenges of ureteral visualization using a ... FUC may improve the safety of MIS and reduce blood loss in addition to preventing ureteral injury and is expected to have oncological ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230019D.pdf

Point of Care GFR Assessment FACT SHEET FOR PATIENTS The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the.

5. innovate-ir.com innovate-ir.com/node/20611/pdf

MediBeacon® Transdermal GFR System Receives FDA ... The. TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0080892

Ureteral Injury (DBCOND0080892) Associated Data ; NCT04695951. Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract, No drug ...

7. meddatax.com meddatax.com/clinical-trials/NCT07080008

Evaluation of Lumitrace for Visualizing Ureters During ... The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates ...