FINDING YOUR TUMOR DURING SURGERY

Tumor Localization for Early-Stage Breast Cancer

Thanks to advances in early detection, more than 80 percent of women with breast cancer will be diagnosed at an early stage. This means the cancer is localized to the breast tissue and has not spread to other parts of the body.

When breast cancer is diagnosed early, it improves your chances of survival. The 5-year survival rate for women with stage 0 or stage 1 breast cancer is close to 100% (American Cancer Society). It also increases your treatment options.

If you have been diagnosed with early-stage breast cancer, you may be eligible for breast conserving surgery, also known as a lumpectomy, which aims to only remove the cancerous tissue while preserving as much of the breast as possible.

However, many tumors at this stage are so small that they are non-palpable (cannot be felt by touch). As a result, you may need to undergo a localization procedure prior to breast cancer surgery to help guide the surgeon in locating and removing the abnormality.

On this page, you will find information about the different types of localization proceduresquestions to ask your doctor about your localization options, and information about the latest generation of localization technology, known as surgical marker navigation.

What is tumor localization?

Localization is a common procedure used to mark non-palpable breast tumors in order to help surgeons more accurately locate and remove the cancerous tissue during surgery, while also minimizing damage to healthy breast tissue.

It is estimated that 1 in 3 women who undergo breast conserving surgery for early-stage breast cancer in the United States require some form of breast tumor localization (JAMA 2017).

Localization always happens before surgery. Depending on the type of localization used, this may be the same day as your surgery, or several days/weeks prior to your surgery. During the procedure, a radiologist implants a marker or wire into the tumor that will help the surgeon find the location. During surgery, the surgeon removes the localization wire or marker along with the tumor.

What are the different types of localization procedures?

Localization procedures can be divided into two categories – wire-guided and wire-free.

  • Wire-Guided Localization
    Wire localization for breast cancer surgery has been the gold standard since the early 1980s. The procedure involves the insertion of a long, thin wire (approx. 8 inches) in the breast. One end of the wire marks the location of the tumor, while the other end of the wire protrudes from the breast. During surgery, the surgeon follows the wire to locate the tumor for removal.

Because the wire sticks out of the breast and restricts movement, wire localization procedures have to be done the same day as the surgery – which can create scheduling issues between radiology and surgery.

  • Wire-Free Localization
    Wire-free technologies were developed to overcome the many limitations of wire-guided localization. These procedures involve the insertion of a small, fully implantable marker into the tumor using imaging guidance (such as mammography or ultrasound). The marker can be placed before the day of surgery, allowing greater flexibility for scheduling.

During surgery, the surgeon uses a handheld device that detects the marker and provides real-time information about its location relative to the tumor. There are several wire-free devices available which use different technologies to detect the marker.

What are the benefits of wire-free localization?

Wire-free localization overcomes many of the challenges associated with the use of a wire. It is a reliable, accurate and efficient method for surgeons to mark and remove small, early-stage breast tumors with increased precision while also contributing to a better patient experience.

The benefits include:

  • Less discomfort: Eliminates the insertion of a wire, which can be uncomfortable for the patient.
  • More precise: Allows for more precise localization of the lesion, which can lead to more accurate removal of the tumor while sparing healthy breast tissue, potentially reducing the need for additional surgeries.
  • Greater flexibility: Can be performed on lesions that are difficult to reach with a wire, such as those that are deep in the breast tissue. Markers can also be placed prior to the day of surgery, eliminating potential scheduling issues between radiology and surgery.

Surgical Marker Navigation

The latest generation of wire-free localization technology is known as surgical marker navigation. The system uses state-of-the-art navigation technology to mark and remove non-palpable breast tumors with incredible precision and accuracy, potentially enabling smaller, more accurate tissue removal and preventing the unnecessary removal of healthy tissue.

By making breast conserving surgery more precise, surgical marker navigation may help to improve surgical outcomes and may reduce the need for additional surgeries.

HOW DOES IT WORK?

The state-of-the art technology has two main components: a surgical marker and smart surgical navigation system.

The Marker

  • The surgical marker is a tiny, indestructible magnetic seed (roughly the size of a grain of rice), encapsulated in high-grade, nickel-free titanium.
  • Under imaging guidance, the marker is inserted into the target area using a small needle.
  • This quick and easy procedure can be done prior to your surgery day and can even be combined with other appointments as part of your pre-surgery workup.

The Navigation

  • The smart surgical navigation system provides your surgeon with a precise pathway to the targeted abnormality, enabling them to plan the best approach for surgical removal.
  • During surgery, the advanced software provides real-time, directional guidance using both audio and visual feedback.
  • The guidance includes a unique locking feature called TargetLOC™ that enables your surgeon to visualize when they are perfectly aligned with the target, allowing for pinpoint accuracy.

Why Precision & Accuracy Matter

The goal of breast conserving surgery is to completely remove the cancer while preserving as much of the breast as possible – ideally in a single operation.

Unfortunately, this is not always possible. Almost one in five patients may require additional surgery to remove remaining cancerous tissue after the initial lumpectomy. Multiple surgeries mean additional discomfort and stress for the patient, as well as potentially delaying subsequent treatments.

By improving the precision and accuracy of localization, surgical marker navigation makes it easier for the surgeon to remove an adequate margin of normal tissue surrounding the tumor, while sparing as much healthy tissue as possible. This may increase the likelihood of complete tumor removal, and potentially reduce the need for additional surgeries.

Localization Options - Questions to ask your surgeon

Frequently Asked Questions

Is the Pintuition system cleared by the Food and Drug Administration (FDA)?

Yes, the Pintuition System is cleared by the FDA.

No. Pintuition is an alternative to wire localization and it eliminates the scheduling issues of having a wire placed on the day of surgery. It can help make the surgery day shorter and may help reduce patient anxiety.

The marker consists of a tiny magnet no bigger than a grain of rice. It is encapsulated in high-grade, nickel-free biocompatible titanium.

The marker can be placed up to 30 days before the day of surgery. This simple procedure can be combined with other appointments as part of your pre-surgery work up.

The marker is placed using radiographic imaging guidance, for example ultrasound or mammography.

There are no limitations after the marker has been placed. Please consult with your doctor for specific recommendations.

No. The marker is passive and cannot be used to track you in any way. It does not contain a uniquely identifiable number or any other feature that would allow that.

Yes, the marker is removed together with the target tissue during your surgery.

Insights from our medical advisor

“Surgical marker navigation is transforming the way breast conserving surgery is performed. While localization gives direction, surgical marker navigation provides distance, direction, and precise location. It’s like going from navigating with a compass to a state-of-the-art GPS system that’s faster, more accurate and easier to use. Putting precise surgical navigation into the hands of skilled surgeons will undoubtedly improve the care they’re able to provide for patients with breast cancer.”

Barry Rosen, MD, FACS

Breast Surgical Oncologist, Chicago, IL & LLL Senior Medical Advisor

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