Using a new dye to improve ureter visibility during surgery
A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
This study is testing a new dye to see if it helps surgeons see the ureter more clearly during certain surgeries for adults, including those with mild kidney issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Locations | 9 sites (Newport Beach, California and 8 other locations) |
| Trial ID | NCT05999747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing abdominopelvic surgery who have either normal renal function or mild chronic kidney disease.
Not a fit: Patients with severe chronic kidney disease or those not scheduled for relevant surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of ureteral injuries during surgery, leading to better surgical outcomes.
How similar studies have performed: Other studies using near-infrared fluorescence for surgical visualization have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Newport Beach, California and 8 other locations
- 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)
- Firsthealth of the Carolinas INC — Pinehurst, North Carolina, United States (Recruiting)
- Temple University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Astellas Pharma Global Development, Inc.
- Email: astellas.registration@astellas.com
- Phone: 800-888-7704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.