Medical Dye for Abdominal Surgery
Trial Summary
What is the purpose of this trial?
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This study is about a potential new medical dye, called ASP5354. This dye is injected into the person at the start of surgery and is detected in the ureter. This is done by an imaging machine which has an option called near infrared fluorescence, or NIR-F. Together they show live images of specific parts of the body. In this study, ASP5354 is used with an imaging machine with a NIR-F option to show live images of the ureter during surgery. People with kidneys that work properly and those with kidney problems can take part in this study. The main goal of the study is to find out how clearly the ureter can be seen with ASP5354 during surgery in people whose kidneys work properly or who have mild kidney problems. To do this, the surgeons will inject ASP5354 into the person having surgery. Then, the surgeons will compare images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light is the standard way surgeons see the ureter during surgery. People 18 years or older, with or without kidney disease, who were going to have certain abdominal surgeries may be able to take part. Everyone taking part will receive ASP5354 during surgery, but how the imaging is done will depend on which group they are in. Before surgery, the people whose kidneys work properly or who have mild kidney problems will be assigned into 1 of 2 groups by chance alone. Images of the ureter will be checked in 1 group using normal white light and the other group using normal white light and NIR-F. People with more severe kidney problems will not be assigned to 1 of 2 groups: all images of the ureter will be checked using normal white light and NIR-F. At the start of surgery, the surgeon will inject ASP5354 into the person having surgery, then will start recording a video of the surgery. Then, after 30 minutes, the surgeon will record how well the ureter can be seen. This will be done by either using normal white light, or normal white light and NIR-F, depending on which group each person having surgery is assigned. For the group to be checked with normal white light and NIR-F, the surgeon will do this check every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon will only do this check after the first 30 minutes. A group of medical experts will also record how well the ureter can be seen in the surgery videos. The medical experts will not be directly involved in this study. They won't know who the images belong to or which group they are from. During the study, people will visit the study hospital 3 times. The first visit is to check if they can take part in the study. People will be asked about their medical history, have a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they will have some blood and urine tests. For women this may include a pregnancy test. People will have their surgery at the second visit. This will be within 28 days of their first visit. This includes having some blood and urine tests before, during, and after surgery. Also, they will have a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and have their vital signs checked. After surgery, people will return to the clinic 10 days later for a final check-up. They will be asked if they have had any medical problems. Also, they will have a medical examination, have their vital signs checked, and have blood and urine tests.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken certain imaging agents within 48 hours before the study dye is given, or if you are on dialysis.
How does the medical dye used in abdominal surgery differ from other treatments?
The medical dye used in abdominal surgery is unique because it employs near-infrared fluorescence imaging to provide real-time visualization of the ureters, reducing the risk of injury during surgery. This approach is less invasive compared to traditional methods like ureteral stents and offers a safer, more efficient way to identify ureters during procedures.12345
Research Team
Medical Monitor
Principal Investigator
Astellas Pharma Global Development, Inc.
Eligibility Criteria
This trial is for adults needing certain abdominal surgeries, with normal or mildly impaired kidney function (eGFR ≥ 60 mL/min) or moderate to severe impairment (eGFR ≥ 15 to < 60 mL/min). Women must not be pregnant, breastfeeding, or donating eggs and agree to use contraception. Men must not donate sperm and if their partner can bear children, they should use contraception.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery where ASP5354 is administered and imaging is conducted using normal white light and/or NIR-F
Follow-up
Participants return for a final check-up to monitor for any medical problems and conduct additional tests
Safety Monitoring
Participants are monitored for adverse events and vital sign abnormalities
Treatment Details
Interventions
- ASP5354 (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available