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Medical Dye for Ureter Visualization During Surgery
Phase 3
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 45 minutes after asp5354 administration (day 1)
Awards & highlights
Study Summary
This trial is testing a new medical dye, ASP5354, which is injected into the person at the start of surgery and is detected in the ureter. It is used with an imaging machine to show live images of the ureter during surgery. Its aim is to make it easier for surgeons to see the ureter during abdominal surgery, reducing the risk of injuring it.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified in detail but may include reactions related to hypersensitivity to the dye components, which could manifest as allergic reactions or other intolerance symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 45 minutes after asp5354 administration (day 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 45 minutes after asp5354 administration (day 1)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intra-participant difference in ureter conspicuity for white light (WL) versus near-infrared fluorescence (NIR-F) for adults with normal renal function or mild renal impairment
Secondary outcome measures
Inter-rater reliability between the surgeons and BICR for the WL versus NIR-F for adults with normal renal function or mild renal impairment
Inter-rater reliability between the surgeons and BICR for the WL versus the average of all NIR-F time points for adults with normal renal function or mild renal impairment
Inter-rater reliability between the surgeons and BICR for the WL versus the end of surgery time point score with NIR-F for adults with normal renal function or mild renal impairment
+33 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairmentExperimental Treatment1 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 impairmentExperimental Treatment1 Intervention
Adult participants with moderate or severe renal impairment will receive a single dose of ASP5354.
Group III: White Light/near-infrared fluorescence - AdolescentsExperimental Treatment1 Intervention
Adolescent participants will receive a single dose of ASP5354.
Group IV: White Light - Adults with normal renal function or mild renal impairmentExperimental Treatment1 Intervention
Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pudexacianinium chloride
2022
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,979 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.
1,660 Previous Clinical Trials
983,722 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for a urinary tract infection.My body weight is less than 30 kg.I have previously been treated with ASP5354.I will likely need a tube placed in my ureter during surgery.I have received a special dye for imaging tests within the last 2 days.I have a lab result that may prevent me from having surgery.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.I am currently undergoing dialysis treatment.I am not pregnant and follow the required birth control measures.My kidney function, measured by eGFR, fits within the study's criteria.
Research Study Groups:
This trial has the following groups:- Group 1: White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment
- Group 2: White Light - Adults with normal renal function or mild renal impairment
- Group 3: White Light/near-infrared fluorescence - Adolescents
- Group 4: White Light/near-infrared fluorescence - Adults with moderate or severe renal impairment
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enrolled in this clinical research?
"Affirmative. The details of this clinical trial, initially released on June 30th 2023 and modified for the last time on July 17th 2023, are available via clinicaltrials.gov and reveal that active recruitment is occurring for a total of 104 individuals from one site."
Answered by AI
Is this trial recruiting participants at the moment?
"Affirmative. According to the information hosted on clinicaltrials.gov, recruitment for this medical trial is taking place presently. The study was first uploaded onto the website on June 30th 2023 and its data has been recently updated as of July 17th 2023. It requires 104 participants from 1 site in total."
Answered by AI
What main goals are this investigation attempting to achieve?
"This clinical trial's primary purpose is to analyze the contrast in ureter visibility between white light and near-infrared fluorescence over 45 minutes post ASP5354 administration. Secondary objectives involve comparing intra-participant scores of ureter conspicuity among adults with varying renal function, using a 5 point Likert scale."
Answered by AI
Has the FDA sanctioned White Light - Adults with normal renal function or mild renal impairment?
"There is prior clinical evidence that validates White Light - Adults with normal renal function or mild renal impairment's safety, thus it has received a score of 3."
Answered by AI
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