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Device Detects Residual Cancer in Lumpectomy Tissue

PathoS' ClearView device

PathoS’ ClearView device (Will Kirk, Homewood Photo/Johns Hopkins University)

Biomedical engineering graduate students at Johns Hopkins University in Baltimore developed a device that allows pathologists to quickly test excised tissue from breast cancer patients undergoing lumpectomies to determine if all of the tumor is removed. The device, still a prototype, has received awards in student engineering and business competitions, and its continued development is funded by a foundation grant.

The Johns Hopkins grad student team of Hector Neira, Vaishakhi Mayya, Anjana Sinha, and Qing Xiang Yee created the device, called PathoS’ ClearView, to meet the needs of breast cancer patients who have lumpectomies that remove the cancerous tissue while preserving the breast. Testing the excised tissue for remaining cancer requires an extended period, often going well past the time needed for the initial surgery. Because of this delay, one in five of the 330,000 annual lumpectomy patients in the U.S. need to return for a second surgery to remove residual cancer cells.

One of the problems encountered by pathologists who test for remaining breast cancer evidence is the nature of the breast tissue itself. When surgeons remove most tumors, pathologists flash-freeze the cancerous tissue, then take thin sample slices for microscopic inspection. If cancer is found on the outer edges of the sample, the surgeon is asked to remove more tissue for further analysis.

Breast tissue, however, poses problems for this procedure because of its higher fat content that can smear or form gaps, which makes it difficult to review as quickly as tissue from other organs. As a result, breast tissue samples take longer to analyze, and thus in many cases, the results are not known until well after the initial surgery. If the first results show cancer remaining in the patient, another round of surgery and testing is required.

The device created by the Johns Hopkins grad students, which they say is low in cost, stabilizes the tissue by adding an adhesive film to the breast tissue before it is sliced that supports the fragile sample and protects it from damage during the slicing process. The adhesive film is disposable and applicator is reusable.

When used in an lumpectomy, say the students, the device makes it possible for a pathologist to review the sample tissue within 20 minutes. If the first results show evidence of residual cancer, the additional tissue samples can be taken during the same surgery as the first samples, reducing the need for a second procedure.

In this year’s Design Day competition, an annual design competition for engineering students at Johns Hopkins held in May, the PathoS device won the People’s Choice award, and the students’ business plan received some $40,000 in prize money at college competitions. The prototype device has been tested on samples from animals and tissue banks, but not yet in a clinical study.

While all four students received their masters degrees in May, two of the students remain at Johns Hopkins to continue developing the device. Their work over this year is supported by the Wallace H. Coulter Foundation.

In the following brief video, Qing Xiang Yee tells more about and shows the device at work.

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