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pudexacianinium chloride for Sentinel Lymph Node Biopsy

Phase 2
Waitlist Available
Research Sponsored by Astellas Pharma 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 10 days
Awards & highlights

Study Summary

This trial is for women with breast cancer and adults with melanoma. The goal is to find the best dose of ASP5354, which will help doctors see the lymph nodes more clearly during surgery.

Eligible Conditions
  • Sentinel Lymph Node Biopsy
  • Melanoma
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Optimal dose of ASP5354 for lymph node (LN) visualization
Secondary outcome measures
Therapeutic procedure
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with laboratory value abnormalities and/or AEs
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: MelanomaExperimental Treatment1 Intervention
Participants will receive a single dose of ASP5354. Up to 5 dose levels will be administered.
Group II: Breast CancerExperimental Treatment1 Intervention
Participants will receive a single dose of ASP5354. Up to 6 dose levels will be administered.
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 IncLead Sponsor
690 Previous Clinical Trials
232,038 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Inc
1,649 Previous Clinical Trials
979,724 Total Patients Enrolled

Media Library

pudexacianinium chloride Clinical Trial Eligibility Overview. Trial Name: NCT05457842 — Phase 2
Sentinel Lymph Node Biopsy Research Study Groups: Breast Cancer, Melanoma
Sentinel Lymph Node Biopsy Clinical Trial 2023: pudexacianinium chloride Highlights & Side Effects. Trial Name: NCT05457842 — Phase 2
pudexacianinium chloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457842 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment count for this research experiment?

"Affirmative. Clinicaltrials.gov indicates that this experiment is actively recruiting participants, having been first posted on August 10th 2022 and most recently updated November 11th of the same year. The study necessitates 132 individuals over 2 sites to participate."

Answered by AI

Are there still openings available for participants in this medical experiment?

"Per the data available on clinicaltrials.gov, this experiment is still recruiting volunteers and was first made publically accessible on August 10th 2022 with its last edit occuring November 11th of the same year."

Answered by AI

Has the U.S Food and Drug Administration given its blessing to pudexacianinium chloride?

"Based on the information that is available, our team at Power judged pudexacianinium chloride to have a safety rating of 2. This drug has been through Phase Two trials with evidence suggesting its security but not yet definitively confirming its efficacy."

Answered by AI
~0 spots leftby Apr 2025