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pudexacianinium chloride for Sentinel Lymph Node Biopsy
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.
- Sentinel Lymph Node Biopsy
- Melanoma
- Breast Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Breast Cancer
- Group 2: Melanoma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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