Currently, women undergoing a lumpectomy to remove a cancerous breast tumor have to wait five to seven days after their initial surgery to learn whether a second surgery is necessary. It typically takes pathologists that long to determine whether the surgeon has removed all the cancerous cells in the breast.

Now, with the use of a testing device called MarginProbe, surgical oncologists can know immediately—while the patient is still in surgery—if they've missed any cancerous cells.

The goal of a lumpectomy is to completely remove the cancerous tumor while preserving as much of the patient's normal breast tissue as possible. The surgeon wants to see only healthy tissue surrounding the removed tumor. But in up to 60 percent of cases, cancerous tissue is missed and the patient has to return to the operating room.

Surgeons at UC Irvine Medical Center are the first in the country to use the MarginProbe System, a specimen testing device that can determine with 50-percent certainty whether the edges, or margins, of the removed tissue are “clean.” 

Alice Police, M.D., a surgical oncologist at UC Irvine, began using MarginProbe in March."This new technology is a game changer for early-stage breast cancer surgery, and we’re already seeing better results," she said in an interview with Healthline.

“The nature of breast cancer cells is such that the pathologist cannot accurately assess a frozen section during surgery,” Police explained. Although the pathology testing step will still be necessary, MarginProbe reduces the need for re-operation by 56 percent, according to the results of an FDA trial.

The MarginProbe System consists of a sterile handheld probe and a portable console. When the probe tip touches a specimen of tissue removed during a lumpectomy, electromagnetic signals are transmitted into the tissue and captured in the console, where they are analyzed using a specialized algorithm to determine the status of the sample.

No Rationale for a Full Mastectomy

According to Police, up to two-thirds of the 200,000 new cases of breast cancer diagnosed each year are Stage 1 or 2 cancers, making lumpectomy the standard of care.

“There is no rationale for removing the entire breast to improve the odds of a long-term cure. The five-year survival rate for lumpectomy with irradiation is nearly 100 percent, and long-term the rate of survival is 85 to 90 percent,” Police said.  

A 20-year follow-up study of standard breast cancer treatments published in 2010 in the New England Journal of Medicine found no significant difference in survival rates between a full mastectomy and breast-conserving surgery with radiation treatment.

“Lumpectomy followed by breast irradiation continues to be an appropriate therapy for women with breast cancer, provided that the margins of resected specimens are free of tumor,” study author Bernard Fisher, M.D., and his colleagues concluded.

FDA Approval of MarginProbe

MarginProbe was developed by Dune Medical Devices and approved for use in breast lumpectomy surgery by the Food & Drug Administration (FDA) in December 2012.

UC Irvine Medical Center participated in a clinical trial of MarginProbe that included more than 660 women across the U.S. In the randomized, multi-center study, surgeons applied the device to tissue removed during surgery and, if the test indicated remaining cancer cells, shaved away additional tissue on the spot.

MarginProbe is now being tested for use during prostate cancer surgery.

In Line with the Goals of Healthcare Reform

The primary goal of healthcare reform initiatives is to reduce the cost of healthcare while improving the quality of care and patient outcomes.

By reducing the number of required re-operations, MarginProbe will generate savings of up to $6,000 per repeat surgery, according to Police. “Most importantly, MarginProbe will help us improve care quality and reduce stress on patients,” she said.

Getting additional cancer treatment centers and insurance companies on board is the next step toward making MarginProbe available to breast cancer patients across the country.

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