Technological advances offer an added advantage to women facing breast cancer surgery.

Breast surgeons now have the option of using a new technology to help them achieve clean margins in lumpectomies.

marginprobe-device

The MarginProbe® System is a FDA-approved technology that provides surgeons, for the first time, with the ability to perform an intraoperative margin assessment. In approximately five minutes, within the operating room, surgeons can now have immediate information about the presence of cancer cells on the margins of the excised tumor. Learn more about how it works.

The Importance of Negative Margins

A lumpectomy is a challenging surgical procedure, complicated by two obvious yet conflicting priorities: excise as much tissue as necessary to remove the cancer from the breast, remove as little tissue as possible to achieve the best cosmetic result.

Clinically stated, the objective is a clean, negative margin, with all six surfaces of an excised tumor cancer-free.

However, determining if the margins are clean requires the work of a pathologist reviewing tissue long past the conclusion of the surgical procedure. Intraoperative margin assessment consists primarily of visual inspection, palpation, and specimen imaging techniques which surgeons agree are less than reliable.

The MarginProbe System is designed to give today’s surgeons a significant new advantage in margin assessment. In a procedure of roughly five minutes, MarginProbe provides real time, detailed information to help a surgeon decide whether additional tissue should be taken, or whether to complete the lumpectomy procedure, and close the incision. Surgeons can perform the intraoperative assessments themselves, using the advanced technologies of the MarginProbe System. It’s a novel tool that gives surgeons an excellent chance of making a correct margin assessment before the tissue is examined by a pathologist.

As a patient grappling with all the frightening aspects of breast cancer, how welcome is the news from the pathologist that the margins on your tumor were negative. Now you know that the worst is behind you, that the cancer has been removed . . . and that you can move on to the next steps of your treatment.

How It Works

There is significant evidence that negative margins are critical in lumpectomies in order to achieve low rates of recurrence equivalent to mastectomies, as well as equivalent survival rates.1 However, with modern diagnostic methods identifying cancer at much earlier stages, and locating much smaller lesions, and with an increase in DCIS diagnoses, obtaining negative margins is becoming increasingly difficult.

Positive margins—identified by pathologists long after the initial surgery procedure is completed—present numerous medical challenges, as well as emotional challenges for the patient and her family. Second surgeries may not be possible. If they can be performed, there are cosmetic implications, additional exposure to anesthesia risks, and delays in radiation and/or chemotherapy. Additionally, when oncoplastic techniques are used during a lumpectomy, there could be other surgical difficulties if positive margins are confirmed at a later date.

Until now, with most lumpectomies, attempts at intraoperative margin assessment—using palpation, visual inspection, and specimen imaging—are considered less than ideal.

In most cases, positive margins require a second surgical procedure.  Depending upon the type of cancer, re-excision rates have run from 22% of lumpectomies2 to 36% and higher when DCIS is present3.

MarginProbe can make a difference

Intraoperative assessment with the MarginProbe System can be performed by surgeons themselves immediately following the removal of tissue from the breast. A sterile, single-use sensor —attached to a handheld probe—delivers a small area radio frequency (RF) signal to the tissue and captures reflected signals. Information from the reflected signals is sent to the MarginProbe console for analysis. Using a proprietary algorithm, comparisons are made to reflected signals from thousands of other tissue specimens. Results are then displayed for the surgeon—either positive or negative for cancer cells on each of six tissue surfaces.  The surgeon can then decide, immediately, if additional tissue removal is required.

1. N Engl J Med. 2002;347(16):1233-1241.
2. Expert Rev. Anticancer Ther. 8(8), 1193-1196 (2008), Eur. J. Cancer 39, 932–944 (2003), JAMA. 2012;307(5):467-475
3. Meijnen, Ann Surg Onc (2007) 15(1): 23-243, Mod Path (2008) 21: 39-45

 

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