Breast conserving surgery Trials in Disease

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

This clinical trial is taking place in Belgium and focuses on improving surgical outcomes for women with early-stage invasive breast cancer who are planning to have breast-conserving surgery. The study uses a special imaging technique to help surgeons ensure that all cancerous tissue is removed during the operation.

Who can participate:

• Women aged 18 years or older
• Those with a confirmed diagnosis of ductal invasive breast cancer, meaning a tissue sample has been examined under a microscope and confirmed to be this type of cancer
• Patients with primary early-stage invasive breast cancer (stages T1 or T2), which refers to smaller tumors that have not spread extensively
• Women who have not had previous breast cancer surgery on the affected breast
• Patients with an ECOG Performance Status of 0 or 1, meaning they are fully active or have some symptoms but remain nearly fully active in daily life
• Those willing to sign an informed consent form after being fully informed about the study

Who cannot participate:

• Patients who do not have primary invasive early breast cancer in stages T1 or T2
• Those not planning to undergo breast-conserving surgery
• Male patients
• Patients outside the specified age range
• Individuals belonging to vulnerable populations not eligible for this study

What the trial involves:

The main focus of this study is to determine the best way to use a special imaging technique called ICG-fluorescence imaging during breast-conserving surgery. Before surgery, participants receive an injection of a substance called indocyanine green (ICG) into a vein. This dye lights up under a special type of light during surgery, helping surgeons clearly see the edges of the tumor. This ensures that all cancerous tissue is removed while preserving as much healthy breast tissue as possible.

The study aims to find the most effective dose and timing for giving the indocyanine green injection. Researchers will evaluate how accurately this imaging technique detects cancerous tissue at different doses and times. They will also examine how well the breast tumor and nearby lymph nodes show up under the imaging.

Investigational drug:

The study uses indocyanine green (ICG), a fluorescent dye that binds to proteins in the blood and glows under near-infrared light. This property allows surgeons to visualize tumor margins more clearly during surgery, potentially reducing the need for additional operations if any cancerous tissue is left behind.

The trial began recruitment in December 2023 and is expected to continue until 2026.