2023-503241-63-00
Recruiting
Phase 2/3
A Phase 2/3 randomized controlled semi-blinded trial to investigate safety and effectiveness in visualization of the ureters with nizaracianine triflutate, administered intravenously in up to three divided doses, in participants (18 years or older) undergoing abdominopelvic surgical procedures [TRIPHASE Trial].
Curadel Surgical Innovations Inc., Curadel Surgical Innovations Inc., Curadel Surgical Innovations B.V.5 sites in 1 country168 target enrollmentStarted: November 23, 2023Last updated:
Interventionsnizaracianine triflutate
Overview
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Curadel Surgical Innovations Inc., Curadel Surgical Innovations Inc., Curadel Surgical Innovations B.V.
- Enrollment
- 168
- Locations
- 5
- Primary Endpoint
- Phase 2: Determination of the near-optimal dose in the context of an acceptable safety profile
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts 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
- •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
Exclusion Criteria
- •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
Arms & Interventions
nizaracianine triflutate
Experimental
Participants receiving nizaracianine triflutate
Intervention: nizaracianine triflutate (Drug)
Outcomes
Primary Outcomes
Phase 2: Determination of the near-optimal dose in the context of an acceptable safety profile
Phase 2: Determination of the near-optimal dose in the context of an acceptable safety profile
Phase 2 and 3: Safety assessment
Phase 2 and 3: Safety assessment
Phase 2 and 3: The proportion of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified prior to surgery by the surgeon) with a peak SBR ≥ 1.5
Phase 2 and 3: The proportion of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified prior to surgery by the surgeon) with a peak SBR ≥ 1.5
Secondary Outcomes
- i. Proportion of cases in which ureter identification did not require invasive procedures or dissection of surrounding tissue
- ii. Average time required for initial ureter identification (minutes)
- iii. Proportion of cases for which ureter integrity status (leak vs. no leak) and function (flow/obstructions) were determined at closing without the need for invasive procedures and/or tissue manipulation
- iv. Among cases that normally require ureter skeletonization/ureter dissection, the proportion of cases where skeletonization/ureter dissection could be reduced or eliminated
- v. Average time period of ureter visualization provided by the first dose of nizaracianine
- vi. Average dose interval and average number of doses of nizaracianine preferred by surgeons for optimal visualization of the ureters during surgeries of various lengths (Phase 3 only)
- vii. Among subjects with ureter injury, the proportion of cases detected intraoperatively
- viii. Among subjects with intraoperative detection of ureter injury, the proportion of cases in which nizaracianine assisted repair
- ix. For a particular surgical procedure type, average overall surgery time (Phase 3A only)
- Exploratory endpoint: i. In bladder-involved cases, the proportion of cases where nizaracianine helped identify bladder anatomy
- Exlporatory endpoint: ii. The proportion of cases where nizaracianine provided NIR fluorescence enhancement of blood vessels in the surgical field
Investigators
John V. Frangioni, M.D., Ph.D.
Scientific
Curadel Surgical Innovations Inc.
Study Sites (5)
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