The purpose of this study is to determine how long collagen based marker clips remain
visible by ultrasound after placement in suspicious breast lesions and if collagen based
marker clips can be reliably identified in the operating room and serve as effective
guidance for surgical removal of high risk or malignant breast lesions.
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).
- Patients with suspicious breast lesions that have undergone biopsy and marker clip
placement within 28 days (4 weeks) of pre-operative consultation visit.
- Patients or their legal representative must be able to provide written informed
- Patients must be over 18 years old.
- Under the age of 18 years
- Unable to give written informed consent
- Patients will be excluded if the clip was placed more than 4 weeks prior to their
pre-operative appointment or wire-localization.