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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 predose, approximately 10 minutes, 30 minutes, 60 minutes postdose, and at the end of surgery (day 1)
Awards & highlights
No Placebo-Only Group
Summary
This trial tested a new dye called ASP5354 in women with breast cancer and adults with melanoma. The dye helps surgeons see lymph nodes more clearly during surgery to check if cancer has spread. The goal was to find the best dose of ASP5354 for this purpose.
Eligible Conditions
- Sentinel Lymph Node Biopsy
- Melanoma
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, approximately 10 minutes, 30 minutes, 60 minutes postdose, and at the end of surgery (day 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, approximately 10 minutes, 30 minutes, 60 minutes postdose, and at the end of surgery (day 1)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Optimal Dose of ASP5354 for Lymph Node (LN) Visualization
Secondary study objectives
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Percentage of Identified LN Tissue by ASP5354 Compared With SOC Treatment
Percentage of Participants With at Least 1 LN Detected Using ASP5354
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ASP5354 0.2 mgExperimental Treatment1 Intervention
Participant received a single dose of 0.2 milligrams (mg) intradermal injection of ASP5354 on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pudexacianinium chloride
2022
Completed Phase 1
~30
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Who is running the clinical trial?
Astellas Pharma IncLead Sponsor
695 Previous Clinical Trials
233,307 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Inc
1,675 Previous Clinical Trials
988,797 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have confirmed lymph node spread of the cancer.You have early stage breast cancer or melanoma and are scheduled for a specific type of lymph node detection and removal surgery as part of your standard care.You had surgery to remove lymph nodes in the area where we need to check the lymph nodes.You have had radiation treatment in the area where lymph nodes need to be checked.You drink a lot of alcohol or use illegal drugs, or have used them within 24 hours before surgery.You have received chemotherapy before surgery.You have cancer that has spread to other parts of the body.You have taken ASP5354 before.Your resting heart rate is too slow or too fast, or your blood pressure is too high. If your blood pressure is too high, it can be checked again to make sure. If your blood pressure is well controlled, you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: ASP5354 0.2 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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