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Device gets breast tumor first time around

JOHNS HOPKINS (US) — A new tool can help surgeons remove breast cancer tumors completely the first time, which may help prevent costly and potentially risky second surgeries.

The device would speed up pathology examinations of excised breast tissue, allowing an exam to be completed in 20 minutes, while the patient is still in the operating room. If microscopic inspection indicates that some cancer cells remain behind, a surgeon can go back in and remove them without scheduling a second lumpectomy.

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Besides saving money and avoiding the risks and anxiety inherent in any surgery, eliminating repeat operations would help patients sidestep delays in starting important follow-up therapies such as radiation or chemotherapy.

“We spoke to breast cancer surgeons,” says Hector Neira, one of the biomedical engineering graduate students at Johns Hopkins University who invented the device.

“They told us that they are desperate for something that will allow them to remove the tumor in its entirety the first time, so that the patient doesn’t have to come back for a second surgery.”

In lumpectomies, unlike mastectomies, surgeons remove diseased tissue while preserving the breast. But because of the pathology exam delay, one in five women—up to 66,000 patients annually in the United States alone—have to return for a second surgery to remove remaining cancer.

The device is still in its prototype stage, but the students say their goal is to give breast cancer patients the same rapid review that commonly occurs when tumors are removed elsewhere in the body.

With most excised tumors, such as those from the liver, pathology staff quickly flash-freeze the tissue and slice off paper-thin samples for microscopic examination. If the pathologist sees cancer cells extending to the outer edge of a sample, the surgeon is advised to remove more tissue.

But breast tissue poses a problem: It possesses a high fat content and does not freeze well, causing the samples to smear, form gaps, and become unsuitable for a quick review. Instead, breast tissue must be preserved and analyzed in a more time-consuming process and the patient must return to the operating room if the first surgery appears to have left cancer cells behind.

A better slice

The graduate students brainstormed for an engineering solution. Their most promising and practical idea was a device that applies an adhesive film to the breast tissue before it is sliced. The film holds the delicate tissue together, preventing damage to the samples during the slicing process. The result, the students say, is a sample that can be clearly reviewed by a pathologist within 20 minutes of its removal.

The low-cost system includes a reusable applicator and a proprietary disposable film. The need for the product is significant, the students say, citing the estimated 330,000 lumpectomies performed annually in the United States alone.

“I think the students have been incredibly creative in their development of this concept, and they are addressing a very real need in the field of breast cancer surgery,” says Melissa Camp, assistant professor of surgery who worked with the team. “Accurate assessment of margin status during the initial operation will lead to fewer re-operations, and this will be beneficial for patients in many respects.”

So far, the system has been tested on animal tissue and human breast samples from a tissue bank, but it has not yet been used on patients. Over the past year, however, the students’ device design and market analysis have earned them more than $40,000 in college business plan competition prizes, money that will help support refinement and testing.

In the recent Design Day event for Johns Hopkins biomedical engineering students, the team received the top People’s Choice award. Although all of the student inventors received their master’s degrees in May, two have received funding to remain at Johns Hopkins and continue the project over the coming year.

Although the financial support and recognition is helpful, “that’s not our ultimate goal,” says Anjana Sinha, another of the inventors. “We’re not doing it for the money. We want to improve health care practices and raise the standard of care for these breast cancer patients. Why can’t they get the same type of quick results that people with other types of cancer receive?”

Other student inventors of the breast cancer device are Qing Xiang Yee of Singapore and Vaishakhi Mayya of India. Sinha and Mayya will remain at Johns Hopkins during the coming year to continue working on the project with David Shin of Seattle, another recent graduate of the CBID master’s program. The Wallace H. Coulter Foundation is providing funding.

Source: Johns Hopkins University

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