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Study on Indocyanine Green for Evaluating Surgical Margins in Patients Undergoing Breast-Conserving Surgery for Early Invasive Breast Cancer

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What is this trial about?

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

This clinical trial is focused on studying breast cancer, specifically in patients with early-stage invasive breast cancer who are planning to undergo breast-conserving surgery. The study will use a special technique called ICG-fluorescence imaging to help evaluate the surgical margins during the operation. The treatment involves the use of a substance called indocyanine green, which is given as an injection and helps to highlight the areas of interest during surgery.

The purpose of the study is to determine the best strategy for using ICG-fluorescence imaging, including the timing and dose of indocyanine green, to accurately assess the surgical margins. This is important to ensure that all cancerous tissue is removed during surgery. The study will compare the accuracy of this technique at different doses and times, and will also look at how well the breast tumor and nearby lymph nodes show up under the imaging.

Participants in the study will receive the indocyanine green injection, and the imaging will be done during their planned surgery. The study aims to find the most effective way to use this imaging technique to help surgeons make sure they have removed all the cancerous tissue. The trial is expected to continue until 2026, with recruitment starting in December 2023.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign a document called an informed consent form. This document confirms that you understand the study and agree to participate.
You will need to meet certain criteria to participate, such as being a female aged 18 or older, having a specific type of breast cancer, and being in good general health as assessed by a performance status score.
Step 2
Pre-surgery preparation
Before your surgery, you will receive a medication called indocyanine green through an injection into your vein. This is known as an intravenous injection.
The purpose of this medication is to help the doctors see the edges of the cancer during surgery using a special imaging technique.
Step 3
Surgery and imaging
During your breast-conserving surgery, the doctors will use a technique called ICG-fluorescence imaging to evaluate the cancer margins. This helps ensure that all cancerous tissue is removed.
The imaging will be done at specific times and doses to determine the best strategy for using this technique.
Step 4
Post-surgery evaluation
After the surgery, the accuracy of the imaging technique will be assessed to see how well it detected any remaining cancerous tissue.
Additional evaluations may include comparing different doses and timings of the medication, as well as examining the fluorescence of lymph nodes near the breast.

Who can join the trial?

7 criteria

Female participants only.
Must be 18 years or older.
Must have a histological diagnosis of ductal invasive breast cancer. This means that a sample of the breast tissue has been examined under a microscope and confirmed to be this type of cancer.
Must have primary early-stage invasive breast cancer (cT1 and/or cT2). This refers to the size and extent of the tumor, which is determined through clinical examination or imaging tests.
No previous breast cancer surgery on the currently affected breast.
ECOG Performance Status of 0 or 1. This is a scale used to assess how a disease affects a patient's daily living abilities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
Must have signed an informed consent form before any study-related procedures. This means you agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

5 criteria

Patients who do not have primary invasive early breast cancer (T1-T2).
Patients who are not planning to have breast-conserving surgery.
Patients who are not female.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population that is not eligible for this study.

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Investigated drugs

ICG is a special dye used in medical imaging. In this trial, it helps doctors see the edges of breast cancer during surgery. The dye lights up when exposed to a certain type of light, making it easier for surgeons to identify and remove cancerous tissue while preserving as much healthy tissue as possible. This process is called fluorescence imaging, and it aims to ensure that all cancer is removed, reducing the chance of needing additional surgery.

Indocyanine Green

What is already known about the treatment

Indocyanine Green (ICG) – Indocyanine Green is administered intravenously and is used in this clinical trial to help surgeons see the edges of breast cancer tumors during surgery. Currently, it is being studied to determine the best dose and timing for its use in breast-conserving surgery for patients with early-stage invasive breast cancer. The main therapeutic indication is to assist in evaluating surgical margins, ensuring that all cancerous tissue is removed while preserving healthy tissue. At the molecular level, ICG works by binding to proteins in the blood and fluorescing under near-infrared light, allowing surgeons to visualize the tumor margins. It is classified as a fluorescent dye used in medical imaging.

Investigated diseases

Primary Invasive Early Breast Cancer – This disease is characterized by the presence of malignant cells that have invaded surrounding breast tissue. It typically begins as a small tumor, classified as T1 or T2, indicating its size and extent of spread within the breast. As the cancer progresses, it may invade nearby lymph nodes, particularly in the axillary region. The growth of the tumor can lead to changes in breast shape or size, and sometimes skin dimpling or nipple discharge. Early stages may not present noticeable symptoms, making regular screenings important for detection. The disease's progression is influenced by various factors, including hormone receptor status and genetic mutations.