visualisation of ureter MedDRA version: 27.0 Level: PT Classification code 10068979 Term: Imaging procedure System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Vizify or pudexacianinium chloride
Product Code: ASP5354
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Pudexacianinium chloride
CAS Number: 2243793-22-6
Con
Sponsors
Astellas Pharma Global Development Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for US study sites) must be obtained from the participant or participant’s parent or legal guardian, and if required, assent from adolescent participant (= 12 to =65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: 1. Participant has any physical or psychiatric condition, which, in the investigator’s opinion, makes the participant unsuitable for study participation. 2. Participant is anticipated to require ureteral stenting during surgery. 3. Participant has an active urinary tract infection requiring antibiotic therapy. 4. Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that the investigator feels would impact safety or study compliance. 5. Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the investigator. 6. Participant with body weight < 30 kg. 7. Participant has a known or suspected hypersensitivity to ASP5354, ICG or any components of the formulation used. 8. Participant has had previous exposure to ASP5354. 9. Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery. 10. Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization. 11. Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigator’s blinded conspicuity assessment of the ureter at the first time point for adults with normal renal function or mild renal impairment;Secondary Objective: Investigator’s conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure for adults with normal renal function or mild renal impairment;Primary end point(s): Intra-participant difference in ureter conspicuity for WL versus NIR F at 30 (± 15) min after ASP5354 administration. Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale;Timepoint(s) of evaluation of this end point: 30 (± 15) min after ASP5354 administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Intra-participant comparison of ureter conspicuity scores for the WL 30 (± 15) min time point versus the average of all NIR-F time points ? Intra-participant comparison of ureter conspicuity scores for the WL 30 (± 15) min time point versus the end of surgery time point score with NIR F ;Timepoint(s) of evaluation of this end point: 30 (± 15) min time point versus the average of all NIR-F time points 30 (± 15) min time point versus the end of surgery time point | — |
Countries
United States
Contacts
Public ContactClinical Trial Unit
Astellas Pharma Europe B.V.
Outcome results
None listed