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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years old
* Scheduled to undergo a medically necessary abdominopelvic surgical procedure expected to last ≥ 2 hours (Phase 2) or any duration (Phase 3), during which one or more ureters should be visualized during the procedure. All abdominopelvic surgical procedures are eligible unless specifically excluded in the Exclusion Criteria.
* For Phase 2, the procedure must require identification of one or both ureters using dissection, mobilization, or other surgical means.
* The planned surgical procedure is open or minimally invasive surgery (MIS), including robotic.
* Both ureters are expected to be present and functional.
* Capable and willing to provide informed consent prior to study-specific procedures
* Screening laboratory test results are within normal limits, or if any are outside of normal limits, they are considered by the site PI, and confirmed by the lead PI, to be clinically insignificant.
* Negative pregnancy test in women of childbearing potential
Exclusion Criteria:
* Known cardiovascular or pulmonary disease, renal or liver dysfunction, immunological disease, diabetes, or active cancer that would render the study subject unfit for surgery
* The planned surgical procedure is renal transplant or nephrectomy \[note: partial nephrectomy is permitted provided that estimated glomerular filtration rate (eGFR) is not expected to fall below normal age-based limits\]
* Prior renal transplant
* Impaired renal function defined as an estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2
* Impaired liver function defined as values \> 1.5 times the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin, or \< lower limit of normal (LLN) for albumin
* Coagulopathy as manifested by international normalized ration (INR) \> 1.3 (unless patient is on anti-coagulants)
* Subjects with a marked baseline prolongation of QT/ corrected QT interval (QTc) interval (e.g., a QTc interval \> 480 msec \[CTCAE grade 1\] using Fridericia's QT correction factor (14)
* History of a clinically significant allergy or anaphylaxis to a component of the investigational medicinal product (IMP)
* Known sensitivity to fluorescent light
* Alcohol or recreational drug use that meets diagnostic and statistical manual of mental disorders (DSM5) criteria for moderate or severe substance use disorder
* Pregnant or breastfeeding, or lack of effective contraception for at least one week post-surgery in male or female subjects with reproductive potential: for males, condom use; for females, oral contraceptives, diaphragm, or intrauterine devices (IUDs)
* Any condition that the investigator considers to be potentially jeopardizing to the study subject's well-being or the study's objectives.
* Participated in an interventional clinical research study within the previous 30 days.
* The planned use of an 800 nm NIR fluorophore that is not Nizaracianine (e.g., indocyanine green or Pafolacianine) immediately before, during, or immediately after the planned abdominopelvic procedure.
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
Official registry record
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.
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