New Cancer Detection Device May Reduce Additional Breast Surgery Operations

Published date : 17 September 2012
Article date : 17 September 2012 reports on a new device called MarginProbe, manufactured by Dune Medical Devices which may soon be available to help surgeons determine the minimal amount of tissue to be removed during a lumpectomy. The tool is designed to detect cancer tissue margins during a surgical procedure which could reduce the need for any subsequent operations. 

They say that a large, prospective trial presented at the American Society of Clinical Oncology Breast Cancer Symposium, San Francisco, shows that when the MarginProbe device is used during surgery, re-excision rates are significantly lower than when no device was used. 

They go on to say that women with invasive carcinomas or DCIS who do not have a high risk of recurrence undergo a lumpectomy followed by radiation therapy rather than a mastectomy. Currently, a pathology review for negative or positive margins is done postsurgery. Re-excision is necessary if positive margins—cancer cells left in the margin of the excised tissue—are found. Typically between 30% and 60% of women need to undergo a second surgery to remove the positive margins.

The results of this trial suggest that margin analysis can be readily done with the MarginProbe device during the initial lumpectomy to obtain negative margins without the need for secondary surgery.

596 patients with either DCIS or invasive carcinoma undergoing a lumpectomy were randomised to analysis with the device or no analysis. The device was used on the main lumpectomy specimen and if positive margins were detected, patients were further resected while in the operating room. The study was conducted internationally at 21 cm.

Apparently, the decrease in the frequency of re-excision between the experimental device and control arms was statistically significant. Of the 161 women in the study who had only DCIS, 13% of those in the device group needed re-excision compared to 37% of those in the control arm (P = .004). For the 334 women with both DCIS and invasive carcinoma, 17% of those in the device arm needed re-excision compared to 33% in the control arm (P < .001). The study found the total tissue, including initial lumpectomy and any subsequent resectioning in patients was the same in both the experimental and control groups. 

The article concludes that more studies are likely to be needed to demonstrate the utility of MarginProbe and that the FDA recently gave the device a positive recommendation. The manufacturer filed a premarket approval with the FDA in May 2011 but as yet, it has not been approved by the FDA.

Source: Anna Azvolinsky,, 14 September 2012

Read the full article here

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