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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Indocyanine Green

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.

Investigated diseases:

Breast cancer

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.

Trial ID:

2024-513163-57-00

NCT ID:

NCT06347354

Trial Phase:

Therapeutic exploratory (Phase II)

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

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