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Medical Dye for Abdominal 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 45 minutes after asp5354 administration (day 1)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new medical dye called ASP5354 that can help surgeons see the ureter more clearly during abdominal surgery. The dye is injected into the patient at the start of surgery and is

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of ASP5354 are not detailed in the provided information but may include reactions at the injection site, allergic responses, or interference with kidney function especially in those who already have kidney problems.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 minutes after asp5354 administration (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intra-participant comparison in ureter conspicuity for white light (WL) versus near -infrared fluorescence (NIR F) at the first time point for participants with normal renal function or mild renal impairment.

Secondary study objectives

CCC, inter-rater reliability between the investigators and BICR for the WL at the first time point versus the end of surgery time point score with NIR-F for participants with normal renal function or mild renal impairment

CCC, the inter-rater reliability between the investigators and BICR for the WL at the first timepoint versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment

Concordance Correlation Coefficient (CCC), the inter-rater reliability between the investigators and BICR for the WL versus NIR-F at the first time point for participants with normal renal function or mild renal impairment

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