A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery

Study Summary

This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. These cells made a substance called melanin which gives the skin its color. In this study, people had surgery to remove the lymph node closest to the site of their cancer. This lymph node was called the sentinel node. This was done to check if the cancer had spread from the original site to the sentinel node. This procedure was called a sentinel node biopsy. This study provided more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 helped to show the lymph nodes more clearly during surgery. This helped the surgeon find the lymph node closest to the site of the cancer (sentinel node). The main aim of the study was to find the best dose of ASP5354 that clearly showed the lymph nodes during surgery. This was an open-label study. That means each person in the study and the study doctors knew that person received ASP5354. Each person only received 1 dose of ASP5354. People that wanted to take part in the study were checked by a study doctor. This was on a separate visit before their surgery. Before surgery, people who took part in the study were asked if they had any other medical problems. They had a physical exam, an ECG to check their heart rhythm, and had their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks included some blood and urine samples taken for laboratory tests. During surgery, a study surgeon injected ASP5354 near the cancer site. They recorded how clearly they could see the lymph nodes. Some blood samples were taken for laboratory tests and an ECG was done. After their surgery, people were asked if they have any other medical problems. People returned to the hospital 9 days later for a check-up. The check-up in

Primary Outcome

The optimal dose was defined as the dose that provided a better visualization compared with lower doses and a comparable visualization to the next higher dose. In the case where 2 doses performed equally, the lower dose was selected. Cumulative visualization data of the LNs from all treated participants was used for optimal dose determination. The optimal dose was determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visuali

Interventions

• DRUG pudexacianinium chloride