Intraoperative Ureter(s) Visualization Using ASP5354 With Near-Infrared Fluorescence Imaging in Minimally Invasive and Open Abdominopelvic Surgeries

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental drug called ASP5354 can assist surgeons in visualizing the ureters during surgery, as well as to assess the safety of ASP5354. The ureters are tubes that transport urine from the kidney to the bladder. Usually, the body has two ureters (one for each kidney). Ureters can be challenging to see during minimally invasive surgeries (performed through small incisions) and open abdominal or pelvic surgeries. As a result, there is a small (1 in 200 or less) chance for surgeons to injure a ureter during surgery. ASP5354 is a dye that is visible on imaging devices and manifests as a green color under near-infrared fluorescence light with special cameras. ASP5354 may improve the surgeons’ ability to identify the ureters during surgery. Study procedures include collection of blood samples, ECG, administration of ASP5354, and ureter visualization tests using both white light and near-infrared fluorescence.

Eligibility

* 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

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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter Visualization When Using ASP5354 with Near-infrared Fluorescence Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

Study Details

Disease Type/Condition

Other

Principal Investigator

Zaghiyan, Karen

Age Group

Adult

Phase

III

IRB Number

STUDY00003758

ClinicalTrials.gov ID

NCT05999747

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org