Recruiting

Study on Indocyanine Green in Axillary Lymph Nodes for Patients with Breast Cancer and Metastatic Lymph Nodes

Registered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the behavior of a substance called Indocyanine Green in patients with Breast Cancer who have cancerous lymph nodes. The trial is known as the FLUO Trial. Indocyanine Green is a chemical used in medical imaging to help doctors see certain areas of the body more clearly. In this study, it is injected under the skin to see how long it stays in the lymph nodes, which are small glands that are part of the immune system and can be affected by cancer.

The purpose of the study is to observe how long the fluorescence, or glow, from Indocyanine Green remains in the axillary lymph nodes, which are located under the arm, after it is injected. This is important for patients who are undergoing surgery to remove these lymph nodes as part of their cancer treatment. The study will take place over a period of up to three weeks, during which the presence of the glowing lymph nodes will be monitored.

Participants in the study will receive a subcutaneous injection, which means the injection is given just under the skin. The study aims to find out how many lymph nodes show fluorescence and how this might vary among different patients. This information could help improve surgical techniques and outcomes for patients with Breast Cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Consent and eligibility
Provide written informed consent before starting any procedures related to the study. This is a document that confirms understanding of the study and agreement to participate.
Ensure eligibility by meeting the criteria: being 18 years or older, having breast cancer with confirmed lymph node metastases, and being eligible for specific surgical procedures.
Step 2
Initial visit and injection
Attend an initial visit where a healthcare professional will administer a subcutaneous injection of indocyanine green. This is a dye used to help visualize lymph nodes.
The dosage of the injection is 2.5 mg.
Step 3
Observation period
After the injection, there is a waiting period of 2-3 weeks to allow the dye to travel to the lymph nodes.
During this time, normal activities can usually be resumed, but follow any specific instructions given by the healthcare team.
Step 4
Surgery and evaluation
Undergo radical axillary surgery, which is a procedure to remove lymph nodes in the armpit area.
During surgery, the presence of the dye in the lymph nodes will be evaluated to determine the permanence of fluorescence.
Step 5
Follow-up
Participate in follow-up visits as required by the study to monitor recovery and gather additional data.
These visits help assess the frequency and characteristics of fluorescent lymph nodes.

Who can join the trial?

3 criteria

Provide written informed consent before starting any study-related procedures. This means you agree to participate after being informed about the study.
Be 18 years old or older.
Have a diagnosis of breast cancer with confirmation that the cancer has spread to the lymph nodes. You must be eligible for surgery to remove part of the breast or the entire breast, along with surgery to remove lymph nodes in the armpit area.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Breast Cancer cannot participate.
Only female patients are eligible; male patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who are part of a vulnerable population cannot participate. This usually includes groups like pregnant women, children, or those unable to give consent, but specifics are not provided here.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Indocyanine Green is a special dye used in medical imaging. In this trial, it is injected under the skin to help doctors see the lymph nodes near the armpit area in patients with breast cancer. The dye makes the lymph nodes glow under a special light, which helps doctors find and examine them during surgery. The study is looking at how long the dye stays in the lymph nodes after it is injected.

Indocyanine Green

What is already known about the treatment

Indocyanine Green – Indocyanine Green is administered through a subcutaneous injection, which means it is injected just under the skin. It is currently being studied in clinical trials for its use in breast cancer patients, specifically to see how long it stays in the lymph nodes after injection. The main therapeutic use being investigated is to help identify lymph nodes affected by cancer during surgery. At the molecular level, Indocyanine Green works by emitting fluorescence when exposed to a specific type of light, which helps surgeons see the lymph nodes more clearly. It is classified as a diagnostic agent in pharmacology.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancerous cells may invade surrounding tissues. The progression can vary, with some forms growing slowly and others more rapidly.