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A Phase 2/3 trial to investigate visualization of the ureters with nizaracianine triflutate, intravenous, in participants aged 18 years or older, undergoing abdominopelvic surgical procedures [TRIPHASE TRIAL].
EU CTIS ID: 2023-503241-63-00
What this study is testing
The Phase 2 primary objectives are (1) to assess the safety of nizaracianine, (2) to assess the efficacy of nizaracianine, and (3) to define the near-optimal dose of nizaracianine for enhancing ureter anatomy and function during surgery using NIR fluorescent light. The Phase 3 primary objectives are (1) to assess the safety of nizaracianine and (2) to assess the efficacy of nizaracianine at its near-optimal dose for enhancing delineation of ureter anatomy (technical benefit) and ureter function (clinical benefit) during surgery using NIR fluorescent light.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- For Phase 2, the procedure must require dissection or mobilization of one or both ureters.
- The planned surgical procedure is open or MIS (including robotic).
- Both ureters are expected to be present and functional.
- Capable and willing to provide informed consent prior to study-specific procedures
You likely can't join if
- This Phase 2 only exclusion was removed. Intentionally left blank
- Impaired renal function defined as an eGFR < 50 mL/min/1.73m2
- Impaired liver function defined as values > 1.5X the ULN for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin, or < LLN for albumin
- Coagulopathy as manifested by INR > 1.3 (unless patient is on anti-coagulants)
- Subjects with a marked baseline prolongation of QT/QTc interval (e.g., a QTc interval > 480 msec [CTCAE grade 1] using Fridericia’s QT correction factor
- History of a clinically significant allergy or anaphylaxis to a component of the IMP
See the full eligibility 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
- For Phase 2, the procedure must require dissection or mobilization of one or both ureters.
- The planned surgical procedure is open or 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, or other medically qualified designee, to be clinically insignificant.
- Negative pregnancy test in women of childbearing potential
- This Phase 2 only exclusion was removed. Intentionally left blank
- Impaired renal function defined as an eGFR < 50 mL/min/1.73m2
- Impaired liver function defined as values > 1.5X the ULN for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin, or < LLN for albumin
- Coagulopathy as manifested by INR > 1.3 (unless patient is on anti-coagulants)
- Subjects with a marked baseline prolongation of QT/QTc interval (e.g., a QTc interval > 480 msec [CTCAE grade 1] using Fridericia’s QT correction factor
- History of a clinically significant allergy or anaphylaxis to a component of the IMP
- 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.
- Known sensitivity to fluorescent light
- Alcohol or recreational drug use that meets 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 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.
- 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 GFR is not expected to fall below normal age-based limits]
- Prior renal transplant
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.