Trial Information

Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement

Many breast cancers and other breast lesions are discovered as a palpable abnormality by
patients or their providers during a breast exam. Diagnostic imaging and biopsy of these
lesions may reveal high-risk or malignant findings. These palpable lesions can be removed
in the operating room by the surgeon using touch as guidance. However, there are many
lesions discovered by screening examinations that surgeons cannot palpate. When this
occurs, a radiologist will percutaneously place a wire or wires at the site of the breast
lesion using sonographic or mammographic guidance. The surgeon then uses the wires as a
guide for complete and successful resection of the lesion.

New marker devices have been developed that are sonographically visible. They consist of
the standard mammographically visible metallic clip surrounded by a sonographically visible
collagen plug. It is hypothesized that radiologists and surgeons can effectively localize
the clip with intra-operative ultrasound and then resect the lesion. If so, the
pre-operative wire localization procedure could be eliminated. This could improve the
patient experience while saving time and money by reducing the number of invasive procedures
from 3 (biopsy, wire-localization and operation) to 2 (biopsy and operation).