Results of a large prospective study on the treatment of early breast cancer presented during the 2012 Breast Cancer Symposium at the San Francisco Marriott Marquis in San Francisco, CA, September 13-15, 2012, determined that the use of a novel device called MarginProbe helps ensure that sufficient tissue is removed during a lumpectomy. This results in fewer additional surgeries helping toavoid cost of having to remove larger amounts of tissue. For patients, this could translate into reduced risks associated with follow-up surgeries and increased odds of preserving the cosmetic appearance of the breast after lumpectomy.

?The goal of a lumpectomy is to remove the cancer with a clear margin and preserve the cosmetic appearance of the breast. We do that by removing less tissue. But we do not want to have a high re-excision rate. This device has shown us, for the first time, that we can reduce the re-excision rate without taking out more volume,? said Susan K. Boolbol, MD, a breast surgeon at Beth Israel Medical Centerand a senior author on the study.

Up to 40% of breast cancer patients have to undergo additional surgeries to remove cancerous tissue left over after an initial lumpectomy. The reason for this high re-excision rate lies in the difficulty of seeing the border between cancerous and healthy tissue in the breast. In current practice, it takes one or two weeks to obtain pathology results that indicate if sufficient tissue was removed in the first operation.

The MarginProbe may shorten this wait time to about five minutes, enabling detection of cancer at or near the surface of removed tumor tissue specimens while the patient is in the operating room. Consequently, the device reduces the risk of obtaining specimens with positive margins, meaning that the edges of the specimen contain some cancer cells. This, in turn, leads to fewer patients having to undergo repeat surgeries.

Study design
In the study, 596 patients, 161 who had pure ductal carcinoma in situ, were randomized in the operating room after standard lumpectomy to MarginProbe and no device (control) groups. In cases where MarginProbe detected cancer cells near the edge of the specimen, surgeons would cut out more tissue in the same surgical procedure. Researchers then compared the volume of tissue removed during the surgery and any extra tissue removed after the device was used to the total volume of tissue removed in initial and any repeat surgeries in the control group. The total tissue volumes were similar in the device and control group (83 cc vs. 76 cc), but the re-excision rates were significantly lower in the device group (13% vs. 37%).

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MarginProbe emits an electric field and senses the returning signal from a tissue specimen. Cancerous tissue is detected based on its characteristic electromagnetic signature, which is different than that of healthy tissue.

Abstract: # 144
Title: Reduced re?excisions while conserving tissue volume resected in DCIS patients.
Authors: Beth Cutler Freedman, Susan K. Boolbol, Costanza Cocilovo, Lorraine Tafra Diagnosis Group Patients Total tissue volume Candidates for re-excision p-value.

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