Using a new dye to improve ureter visibility during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a new medical dye, ASP5354, in enhancing the visibility of the ureter during abdominopelvic surgeries. The dye is injected at the beginning of the procedure and is detected using a near-infrared fluorescence imaging system, allowing surgeons to visualize the ureter in real-time. The study aims to determine how clearly the ureter can be seen in patients with normal kidney function and those with mild chronic kidney disease. Participants will include adults scheduled for minimally invasive or open surgeries that may require ureter identification.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter identification
* Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease formula

  * Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min
  * Adult moderate/severe eGFR cohort: eGFR ≥ 15 to \< 60 mL/min
* Female participant is not pregnant and at least 1 of the following conditions apply:

  * Not a woman of childbearing potential
  * Woman of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
* Female participant must agree not to breastfeed starting at the administration of ASP5354 through 30 days after ASP5354 administration.
* Female participant must not donate ova starting at the administration of ASP5354 through 30 days after ASP5354 administration.
* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception through at least 30 days after ASP5354 administration.
* Male participant must not donate sperm starting at the administration of ASP5354 through 30 days after ASP5354 administration.
* Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy from the start of ASP5354 administration through 30 days after ASP5354 administration.
* Participant agrees not to participate in another interventional study involving unapproved study medications while participating in the present study.

Exclusion Criteria:

* Participant has any physical or psychiatric condition, which makes the participant unsuitable for study participation.
* Participant is anticipated to require ureteral stenting during surgery.
* Participant has an active urinary tract infection requiring antibiotic therapy.
* Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions would impact safety or study compliance.
* Participant has any clinically relevant laboratory abnormality that could contraindicate surgery.
* Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
* Participant has had previous exposure to ASP5354.
* Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery.
* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization.
* Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis.

Where it's running

• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting
• Washington University Center
  Saint Louis, Missouri, United States Recruiting
• University of Nevada, Las Vegas
  Las Vegas, Nevada, United States Recruiting
• Duke University Hospital
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Astellas Pharma Global Development, Inc.
• Email: astellas.registration@astellas.com
• Phone: 800-888-7704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.