Medical Dye for Ureter Visualization During Surgery

Recruiting at 5 trial locations

Overseen By Astellas Pharma Global Development Inc.

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: Antibiotics, NIR-F agents

Disqualifiers: Ureteral stenting, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

107 Participants Needed

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. The main aim of the study is to find out how clearly the ureter can be seen with ASP5354 during surgery in adults 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 12 years or older 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 adults taking part 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 18 years and older with more severe kidney problems and all people under 18 years old 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. 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 which group each person having surgery is assigned to. For the group to be checked with normal white light and NIR-F, the surgeon will do this 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 after the first 30 minutes. 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 and girls 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 15 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 some blood and urine tests.

Research Team

Medical Monitor

Principal Investigator

Astellas Pharma Global Development, Inc.

Eligibility Criteria

This trial is for people aged 12 and older who are scheduled for certain abdominopelvic surgeries where identifying the ureter is necessary. Participants must have normal to mild kidney issues, measured by eGFR. Women must not be pregnant or breastfeeding and agree to contraception guidelines. Men with partners of childbearing potential must also follow contraceptive rules.

Inclusion Criteria

Participant (and/or participant's parent or legal guardian) agrees not to participate in another interventional study while participating in the present study

I am a man who agrees to use birth control with my partner who can have children.

I am scheduled for a surgery in my abdomen or pelvis where they might need to find my ureters.

Exclusion Criteria

Participant has any physical or psychiatric condition which makes the participant unsuitable for study participation

I am currently being treated for a urinary tract infection.

My body weight is less than 30 kg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Treatment

Participants receive ASP5354 during surgery for ureter visualization using NIR-F imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

15 days

1 visit (in-person)

Treatment Details

Interventions

• ASP5354

Trial Overview The study tests a new medical dye called ASP5354, used during surgery to make the ureter visible under near infrared fluorescence (NIR-F) imaging. Participants will receive this dye; their ureters will then be observed using standard white light or NIR-F imaging based on random group assignment.

Participant Groups

Group I: White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment Experimental Treatment 1 Intervention

Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354.

Group II: White Light/near-infrared fluorescence - Adults with moderate or severe renal impairment Experimental Treatment 1 Intervention

Adult participants with moderate or severe renal impairment will receive a single dose of ASP5354.

Group III: White Light/near-infrared fluorescence - Adolescents Experimental Treatment 1 Intervention

Adolescent participants will receive a single dose of ASP5354.

Group IV: White Light - Adults with normal renal function or mild renal impairment Experimental Treatment 1 Intervention

Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354.

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

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