Medical Dye for Abdominal Surgery

No longer recruiting at 12 trial locations

Overseen By Astellas Pharma Global Development, Inc.

Age: 18+

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

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medical dye, ASP5354 (Pudexacianinium chloride), which helps surgeons see the ureter during abdominal surgery. Surgeons inject the dye at the start of surgery, making the ureter visible with a special imaging machine. The trial aims to evaluate the dye's effectiveness in individuals with normal kidney function or mild kidney issues. Adults scheduled for specific abdominal surgeries, with or without kidney disease, may qualify to participate. As a Phase 3 trial, this is the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking surgical aid.

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.

Is there any evidence suggesting that ASP5354 is likely to be safe for humans?

Research has shown that the medical dye ASP5354 is generally safe for people. One study found that doses up to 24 mg can be used safely to help surgeons see the ureter, the tube carrying urine from the kidneys to the bladder, during surgery. In earlier studies, patients who received ASP5354 experienced no major side effects. This suggests that ASP5354 is safe for those undergoing abdominal surgery. However, as with any medical treatment, a small chance of side effects remains, so it is important to consider this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ASP5354 for abdominal surgery because it offers a unique approach by using a medical dye that enhances visibility during procedures. Unlike standard methods that rely solely on white light, ASP5354 combines white light with near-infrared fluorescence, providing improved accuracy in identifying and differentiating tissues. This dual-light approach could lead to more precise surgeries and better outcomes, especially for patients with varying degrees of renal function. By potentially reducing surgical errors and improving recovery times, ASP5354 represents a promising advancement in surgical techniques.

What evidence suggests that ASP5354 is effective for visualizing the ureter during abdominal surgery?

Research has shown that ASP5354, a medical dye, enhances the visibility of the ureter during abdominal surgery. In one study, surgeons observed the ureter glowing under special lights just 30 minutes after injecting ASP5354. This glow helps prevent accidental damage to the ureter. Participants in this trial will receive ASP5354, which works with a special imaging machine using both regular and near-infrared light to provide clearer images than regular light alone. This method is particularly beneficial for patients with kidney problems, as it allows for precise viewing regardless of kidney function. ^{1 3 6 7 8}

Who Is on the Research Team?

Medical Monitor

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

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

Participant agrees not to participate in another interventional study while participating in the present study.

I am not pregnant and follow the required birth control measures.

I agree to use contraception with my partner who can have children.

Exclusion Criteria

Participant has any physical or psychiatric condition unsuitable for study participation

I have a health issue that makes surgery risky for me.

Participant has known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo surgery where ASP5354 is administered and imaging is conducted using normal white light and/or NIR-F

1 day

1 visit (in-person)

Follow-up

Participants return for a final check-up to monitor for any medical problems and conduct additional tests

10 days after surgery

1 visit (in-person)

Safety Monitoring

Participants are monitored for adverse events and vital sign abnormalities

Up to Day 25

What Are the Treatments Tested in This Trial?

Interventions

• ASP5354

Trial Overview The study tests a new medical dye called ASP5354 designed to help surgeons see the ureter more clearly during surgery using near infrared fluorescence imaging. Participants will receive the dye and have their ureters imaged with standard white light and/or NIR-F technology depending on their group assignment.

How Is the Trial Designed?

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 - 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

Published Research Related to This Trial

In a phase 2 study involving adults undergoing laparoscopic colorectal surgery, pudexacianinium (ASP5354) effectively provided intraoperative ureter visualization, with successful fluorescence observed in 5 out of 6 participants at the 1.0 mg dose and all 3 participants at the 3.0 mg dose.

The treatment was found to be safe and well tolerated, with only one mild adverse event related to the drug, indicating that pudexacianinium could be a promising tool for preventing ureteral injuries during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Albert, M., Delgado-Herrera, L., Paruch, J., et al.[2023]

The zwitterionic near-infrared fluorophore ZW800-1 is safe for use in humans and provides effective real-time imaging of ureters during laparoscopic abdominopelvic surgery, helping to prevent iatrogenic injuries.

ZW800-1 is rapidly cleared from the bloodstream and eliminated in urine after a low-dose injection, allowing for quick visualization of ureter structure and function, which lasts for several hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery. de Valk, KS., Handgraaf, HJ., Deken, MM., et al.[2021]

The fluorescent dye UL-766 significantly improves the identification of ureters during laparoscopic surgery in inflamed conditions, allowing visualization within 5-10 minutes after injection, even when surrounding tissue is swollen or red.

This dye not only aids in locating ureters but also helps detect partial ureteral injuries that would be missed using standard laparoscopic techniques, indicating its potential as a valuable tool in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureter Identification In an Inflammatory Pig Model Using a Novel Near-Infrared Fluorescent Dye. Lau, LW., Luciano, M., Schnermann, M., et al.[2022]

Patent blue dye, when mixed with lidocaine hydrochloride, can form water-insoluble precipitates, making it unsuitable for use in parenteral prescriptions, which could affect its efficacy and safety.

The study highlights that patent blue is not approved by the FDA and has reported toxicities, suggesting caution in its clinical use, especially in combination with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of preparations of patent blue (Alphazurine 2G) dye for parenteral use. Newton, DW., Rogers, AG., Becker, CH., et al.[2019]

The systemic injection of the near-infrared dye IRDye800CW-CA allows for effective visualization of ureters during laparoscopic surgery, with all tested pigs successfully identifying the ureters at various doses.

The optimal dose of 60 μg/kg provided high specificity for ureter identification without the need for invasive procedures, potentially reducing complications associated with traditional ureteral stenting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Fluorescent Visualization of the Ureter With Intravenous IRDye800CW. Korb, ML., Huh, WK., Boone, JD., et al.[2022]

Citations

1. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/abs/10.1002/cpdd.1354

Population Pharmacokinetic Modeling and Simulation of ... Pudexacianinium (ASP5354) chloride is an indocyanine green derivative designed to enable enhanced ureter visualization during surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12257873/

Reliability of Likert Scale for Surgeon-Rated Conspicuity ... Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Surg ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05999747

NCT05999747 | A Study to Find Out if ASP5354 Can ... 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 ...

4. clinicaltrials.astellas.com clinicaltrials.astellas.com/study/5354-CL-0301

A study to find out if ASP5354 can clearly help show ... It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10462524/

Pudexacianinium (ASP5354) chloride for ureter visualization ... The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05754333

NCT05754333 | A Study to Find Out if ASP5354 Can ... People 12 years or older who were going to have certain abdominal surgeries could take part. Everyone taking part received ASP5354 during ...

7. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1013

Randomized, Double‐Blind, Controlled Study to Evaluate ... These results support further evaluation of ASP5354 at doses up to 24 mg for intraoperative near-infrared fluorescence ureter visualization.

8. ctv.veeva.com ctv.veeva.com/study/a-study-to-find-out-if-asp5354-can-clearly-help-show-the-ureter-during-surgery-in-people-with-or-wit

A Study to Find Out if ASP5354 Can Clearly Help Show the ... 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 ...