Medical City Plano January 06, 2014

Medical City Plano has become the first hospital in the Dallas/Fort Worth area to deploy the MarginProbe® System, a new FDA-approved tissue-assessment tool for early-stage breast-cancer surgery.

MarginProbe, developed by Boston-based Dune Medical Devices, Inc., is used to quickly assess the electromagnetic properties of cells on the rim or edge of a suspected tumor. Cancer cells, which contain more collagen than healthy cells, have a distinctive electromagnetic “signature.”

The information gathered by MarginProbe significantly improves surgeons’ ability to identify “cancer on the margins” while a patient is still in the operating room. This can reduce the need for a repeat procedure after an initial lumpectomy.

“This device represents a real breakthrough in breast-cancer surgery,” said Charles Gressle, chief executive officer of Medical City Plano. “We’re very excited to be out front in addressing one of the field’s longest standing unmet needs – the need for real-time verification that clear margins have been achieved.”

In a lumpectomy, a breast tumor and a small amount of tissue around it are removed. The surgeon tries to completely remove the cancer and yet leave the breast looking much the same as it did before surgery.
The purpose for removing a little normal tissue surrounding the tumor is to ensure “clear margins” – tissue that does not contain cancer. Those who undergo lumpectomy for the treatment of invasive breast cancer also receive radiation therapy that treats the entire breast.

In clinical trials with lumpectomy patients, MarginProbe was found to be three times more effective than conventional methods at finding cancer on the margins.
“Breast-cancer patients often experience tremendous anxiety and frustration if it turns out a repeat surgery is needed,” said Beth V. Anglin, M.D., the Plano breast surgeon, who, in late 2013, performed North Texas’ first MarginProbe-assisted lumpectomy at TMCP.

“MarginProbe offers these patients additional peace of mind, and the confidence that they can really begin putting their disease in the rearview mirror,” Dr. Anglin said.

It is estimated that 30 to 60 percent of early-stage breast-cancer patients who have an initial lumpectomy will undergo a repeat surgery. This is because cancer cells are found on the rim or edge of the removed tissue, increasing the possibility that the portion of the breast left intact also contains a residue of such cells.

Breast cancer is the most common type of cancer affecting women in the United States, with more than 285,000 women diagnosed each year. Increased breast-screening awareness, along with advances in imaging technology, now catch more breast-cancer cases early in their development, when they are most treatable. In fact, more than half of all breast-cancer diagnoses are for early-stage cancers. In the majority of these cases, the tumor is too small to be felt during a breast exam.

It is estimated that in 60 to 75 percent of breast-cancer cases, patients will undergo a lumpectomy rather than a mastectomy, which involves the removal of the entire breast. When combined with radiation therapy, lumpectomy is as effective as mastectomy – provided there is no cancer on the margins of the tissue removed.

In a conventional lumpectomy, excised tissue is sent to a pathology laboratory to be analyzed for cancer on the margins. It can take a week or more to receive the lab results that determine whether a patient must undergo further surgery.

In the past, inability to know from the outset whether the initial lumpectomy rid the breast of all cancer cells has resulted in repeat surgery rates ranging from 30 to 60 percent.

With MarginProbe, a surgeon needs only five minutes to search for cancer on the margins, while the patient is still under sedation in the operating room. If cancer is found, additional tissue can be removed immediately.