Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
Nizaracianine Triflutate: Participants will receive up to 3 intravenous bolus injections with a minimal interval between doses of 60 minutes (surgeon discretion). Dose will be 1.0 or 2.5 mg depending on trial phase.
Placebo Comparator: In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo
Study summary
The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic surgery. The ureters are thin-wall, collapsible tubes that connect the kidneys to the bladder. They are difficult to see during surgery and are sometimes damaged accidentally. The main questions to answer are: 1) is this drug safe for use in patients undergoing abdominopelvic surgery and 2) can the drug see the ureters while simultaneously providing information about how well they are working. The clinical trial has 3 parts. Surgery patients enrolled in the first part (Phase 2) will receive drug at different doses to determine the best dose. Patients enrolled in the second part (Phase 3A) will be randomly assigned to drug or placebo (sugar), at the best dose from Phase 2, so the two can be compared directly. Patients enrolled in the final part (Phase 3B) will all receive drug at the best dose from Phase 2.
Eligibility
Primary outcome measure(s)
- The fraction of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified by the surgeon at each timepoint), as verified by three independent blinded reviewers. — 1 day (day of surgery)
The proportion of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified by the surgeon at each timepoint) with a peak signal-to-background ratio (SBR) ≥ 1.5 where SBR is signal-to-background ratio - verified by three independent blinded reviewers
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | Recruiting |
| Board of Trustees of Leland Stanford Junior University | Redwood City | California | Recruiting |
| AdventHealth Orlando | Orlando | Florida | Recruiting |
| AdventHealth Tampa | Tampa | Florida | Recruiting |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | Recruiting |
| University Medical Center Groningen | Groningen | Netherlands | Recruiting |
| Martini Hospital | Groningen | Netherlands | Recruiting |
| Leiden University Medical Centre (LUMC) | Leiden | Netherlands | Recruiting |
| Erasmus Medical Centre | Rotterdam | Netherlands | Recruiting |
| Isala Zwolle | Zwolle | Netherlands | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06101745 on ClinicalTrials.gov ↗ ← All trials in the USA