A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
Status:
Recruiting
Trial end date:
2023-02-28
Target enrollment:
Participant gender:
Summary
This study is for women with breast cancer and for adults with melanoma. Breast cancer is a
type of cancer when cells in the breast turn into cancer cells, which may grow out of
control. Melanoma is a type of skin cancer that starts in cells called melanocytes. These
cells make a substance called melanin which gives the skin its color. In this study, people
will have surgery to remove the lymph node closest to the site of their cancer. This lymph
node is called the sentinel node. This is done to check if the cancer has spread from the
original site to the sentinel node. This procedure is called a sentinel node biopsy.
This study will provide more information on a potential new dye, called ASP5354, used in
sentinel node biopsies. ASP5354 may help to show the lymph nodes more clearly during surgery.
This will help the surgeon find the lymph node closest to the site of the cancer (sentinel
node).
The main aim of the study is to find the best dose of ASP5354 that clearly shows the lymph
nodes during surgery. This is an open-label study. That means each person in the study and
the study doctors knew that person received ASP5354.
Each person will only receive 1 dose of ASP5354. This dose will consist of 2 to 4 injections
of ASP5354 around the cancer site. Small groups of people will each receive a different dose
of ASP5354. The first group will receive a low dose of ASP5354. If the lymph nodes are
clearly seen, the next group will receive a lower dose of ASP5354 and the following group
will receive a dose of ASP5354 that is higher than the dose the first group received. Then,
the results will be checked by an independent panel of experts. Depending on the results, the
next groups may start on the current doses of ASP5354 or may receive a higher dose. In this
study, up to 6 doses of ASP5354 may be given, but each person only receives 1 of these doses.
People that want to take part in the study will be checked by a study doctor. This will be on
a separate visit before their surgery. Before surgery, people who take part in the study will
be asked if they have any other medical problems. They will have a physical exam, an ECG to
check their heart rhythm, and have their vital signs checked (blood pressure, pulse rate, and
breathing rate). Other checks will include some blood and urine samples taken for laboratory
tests.
During surgery, a study surgeon will inject ASP5354 near the cancer site. They will record
how clearly they can see the lymph nodes. Some blood samples will be taken for laboratory
tests and an ECG will be done. After their surgery, people will be asked if they have any
other medical problems.
People will return to the hospital 9 days later for a check-up. The check-up will include a
physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood
pressure, pulse rate, and breathing rate). Other checks will include some blood samples taken
for laboratory tests. People will be asked if they have any medical problems and asked to
complete a feedback survey.