MarginProbe®

Clear Margins Matter

With MarginProbe, surgeons can assess the tissue in the operating room to give them greater confidence that they successfully removed all the cancer in the first lumpectomy surgery.

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. MarginProbe makes possible lumpectomy margin assessment while in the operating room.

Margins Matter

A study of 2900 patients resulted in a 50% or greater re-excision reduction.
Ref: 2021 Reid Expert Review

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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.

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Lumpectomy Margins

Why margins matter, and how MarginProbe can help

Lumpectomy margins are the rim of normal tissue surrounding the cancer tumor that is often removed with the tumor during the surgery to ensure the cancer is completely gone. After the procedure, a pathologist examines the removed tissue to check for remaining cancer cells in the lumpectomy margins. Margins free of cancer are considered clean, clear or negative, which is the goal of the surgery. Margins that still have cancer cells are positive and more surgery, or re-excision, may be necessary to remove them.

Checking the margins is typically done during the lumpectomy, but analyzing the margins can take about a week, according to Breastcancer.org. Margins also are checked after surgical biopsy and mastectomy.

A new standard published recently in the Journal of Clinical Oncology suggests that a 2-millimeter clean margin offers enough protections against the recurrence of ductal carcinoma in situ (DCIS) for women treated with lumpectomy and whole-breast radiation. DCIS is the earliest form of cancer or stage 0 cancer.

The guidelines were issued because of disagreement about how big clean margins should be. About 1 in 3 women treated for DCIS has to have more surgery because doctors decide the margins should be bigger, Breastcancer.org reports. Some doctors want 2 mm or more of normal tissue removed and others consider a 1-mm rim of healthy tissue or less to be enough of a clean margin.

Clean lumpectomy margins mean that no cancer cells can be seen in the outer edge of the removed tissue. The pathology report may also say how wide the clear margin is along with the distance between the outer edge of the surrounding tissue removed and the edge of the cancer. No additional surgery is usually needed.

A positive lumpectomy margin means cancer cells come to the edge of the removed tissue. More surgery is usually needed to remove any remaining cancer.