Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery

NCT06101745 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ZW800-001
• Study Type: interventional
• Target: 336
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Injury of Ureter During Surgery (Disorder)

Keywords

Nizaracianine Triflutate; ZW800-1; ureter; ureter visualization; abdominopelvic surgery; Near-infrared; fluorescence imaging; TRIPHASE

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  1 day (day of surgery)

Secondary Outcomes (9)

• The fraction of cases in which ureter identification did not require invasive procedures or dissection of surrounding tissue

  1 day (day of surgery)

• Average time required for initial ureter identification (minutes)

  1 day (day of surgery)

• Fraction 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

  1 day (day of surgery)

• Among cases that normally require ureter skeletonization/ureter dissection, the proportion of cases where skeletonization/ureter dissection could be reduced or eliminated

  1 day (day of surgery)

• Average time period of ureter visualization provided by the first dose of Nizaracianine

  1 day (day of surgery)

Other Outcomes (4)

• In Phase 3A, comparison of the primary outcome measure between treatment and control arms

  1 day (day of surgery)

• In Phase 3B, comparison of the primary outcome measure between NIR imaging and white light imaging in the same subject

  1 day (day of surgery)

• In bladder-involved cases, the fraction of cases where Nizaracianine helped identify bladder anatomy

  1 day (day of surgery)

Study Arms (2)

Nizaracianine Triflutate Study Drug Arm

ACTIVE COMPARATOR

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.

Drug: Nizaracianine Triflutate

Sugar Comparator Arm

PLACEBO COMPARATOR

In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo.

Drug: Placebo Comparator

Interventions

Nizaracianine Triflutate DRUG

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.

Also known as: ZW800-1

Nizaracianine Triflutate Study Drug Arm

Placebo Comparator DRUG

In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo

Also known as: Sugar

Sugar Comparator Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Curadel Surgical Innovations, Inc.: lead
• Leiden University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• University of Massachusetts Chan Medical School, Worcester: collaborator
• Stanford University: collaborator
• Cedars-Sinai Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Martini Hospital Groningen: collaborator
• Isala: collaborator
• AdventHealth: collaborator

Study Sites (10)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Board of Trustees of Leland Stanford Junior University

Redwood City, California, 94063, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

AdventHealth Tampa

Tampa, Florida, 33613, United States

RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ Groningen, Netherlands

RECRUITING

Martini Hospital

Groningen, 9728 NT Groningen, Netherlands

RECRUITING

Leiden University Medical Centre (LUMC)

Leiden, 2333 ZA Leiden, Netherlands

RECRUITING

Erasmus Medical Centre

Rotterdam, 3015 GD Rotterdam, Netherlands

RECRUITING

Isala Zwolle

Zwolle, 8000 GK Zwolle, Netherlands

RECRUITING

Related Publications (1)

• de Valk KS, Handgraaf HJ, Deken MM, Sibinga Mulder BG, Valentijn AR, Terwisscha van Scheltinga AG, Kuil J, van Esdonk MJ, Vuijk J, Bevers RF, Peeters KC, Holman FA, Frangioni JV, Burggraaf J, Vahrmeijer AL. A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery. Nat Commun. 2019 Jul 16;10(1):3118. doi: 10.1038/s41467-019-11014-1.

  PMID: 31311922 BACKGROUND

MeSH Terms

Interventions

ZW800-1 compound; Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• John V Frangioni, M.D., Ph.D.

  Curadel Surgical Innovations, Inc. (CSI)

  STUDY CHAIR

• John V Frangioni, M.D., Ph.D.

  Curadel Surgical Innovations, Inc. (CSI)

  STUDY DIRECTOR

• Alexander L Vahrmeijer, M.D., Ph.D

  Leiden University Medical Centre (LUMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander L Vahrmeijer, M.D., Ph.D.

CONTACT

+31 71 526 9111; a.l.vahrmeijer@lumc.nl

Cedric Pesch, M.D.

CONTACT

+31 71 526 9111; c.m.w.pesch@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 26, 2023
• Study Start: June 28, 2024
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); NL (5)