RECRUITING

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

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Conditions

Injury of Ureter During Surgery (Disorder)Nizaracianine TriflutateZW800-1ureterureter visualizationabdominopelvic surgeryNear-infraredfluorescence imagingTRIPHASE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2/3 Randomized Controlled Semi-blinded Trial to Investigate Safety and Effectiveness in Ureter Visualization With Intravenous Nizaracianine Triflutate, in up to 3 Divided Doses, in Adults Undergoing Abdominopelvic Surgery (TRIPHASE)

Quick Facts

Study Start:2024-06-28
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06101745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years old
  2. * 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.
  3. * For Phase 2, the procedure must require identification of one or both ureters using dissection, mobilization, or other surgical means.
  4. * The planned surgical procedure is open or minimally invasive surgery (MIS), including robotic.
  5. * Both ureters are expected to be present and functional.
  6. * Capable and willing to provide informed consent prior to study-specific procedures
  7. * 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.
  8. * Negative pregnancy test in women of childbearing potential
  1. * Known cardiovascular or pulmonary disease, renal or liver dysfunction, immunological disease, diabetes, or active cancer that would render the study subject unfit for surgery
  2. * The planned surgical procedure is renal transplant or nephrectomy \[note: partial nephrectomy is permitted provided that estimated glomerular filtration rate (eGFR) is not expected to fall below normal age-based limits\]
  3. * Prior renal transplant
  4. * Impaired renal function defined as an estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2
  5. * 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
  6. * Coagulopathy as manifested by international normalized ration (INR) \> 1.3 (unless patient is on anti-coagulants)
  7. * 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)
  8. * History of a clinically significant allergy or anaphylaxis to a component of the investigational medicinal product (IMP)
  9. * Known sensitivity to fluorescent light
  10. * Alcohol or recreational drug use that meets diagnostic and statistical manual of mental disorders (DSM5) criteria for moderate or severe substance use disorder
  11. * 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)
  12. * Any condition that the investigator considers to be potentially jeopardizing to the study subject's well-being or the study's objectives.
  13. * Participated in an interventional clinical research study within the previous 30 days.
  14. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

John V Frangioni, M.D., Ph.D.
STUDY_CHAIR
Curadel Surgical Innovations, Inc. (CSI)
Katherine T Scott, Ph.D.
STUDY_DIRECTOR
Curadel Surgical Innovations, Inc. (CSI)
Alexander L Vahrmeijer, M.D., Ph.D
PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre (LUMC)

Study Locations (Sites)

Board of Trustees of Leland Stanford Junior University
Redwood City, California, 94063
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: Curadel Surgical Innovations, Inc.

  • John V Frangioni, M.D., Ph.D., STUDY_CHAIR, Curadel Surgical Innovations, Inc. (CSI)
  • Katherine T Scott, Ph.D., STUDY_DIRECTOR, Curadel Surgical Innovations, Inc. (CSI)
  • Alexander L Vahrmeijer, M.D., Ph.D, PRINCIPAL_INVESTIGATOR, Leiden University Medical Centre (LUMC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Injury of Ureter During Surgery (Disorder)