Ultrasound visible breast markers: can these be used for preoperative ultrasound guided lesion localisation?

Each participant will have one of six commercially available breast biopsy markers inserted following a stereotactic vacuum assisted core biopsy of one (or more) breast lesion(s). A list of the six markers will be provided to the clinic staff. The order of the markers will be determined by random selection based upon a table of random numbers. They will then be used sequentially starting with the first randomly chosen marker on the list for the first lesion then the next lesion will receive the next marker on the list and so on. When each clip has been used twice a new randomisation will produce a new list and the same process will be repeated. This procedure will be used until sufficient numbers of subjects has been recruited. After clip selection the participant's ID and lesion number will be entered against the marker used on the list so that the next lesion (or participant, if the participant has only one lesion for stereotactic biopsy) will receive the next marker on the list and so on. The radiologist will not be allowed to "choose" which marker is used. The insertion procedure is performed at the end of each stereotactic vacuum assisted biopsy and takes only a few minutes at most to perform. The position of the marker will be checked on an immediate post biopsy mammogram (this is standard procedure) and the visibility of the marker and any post biopsy hematoma will be assessed on a targeted ultrasound immediately after the biopsy is completed (this is an addition to standard practice). Participants whose biopsy results indicate that surgical removal of the lesion is required and who return to our hospital for surgery will have a further targeted ultrasound on the day of surgery, again to assess marker and hematoma visibility to see if preoperative hook-wire localisation can be successfully performed using ultrasound rather than stereotactic guidance (the metal component of each biopsy marker is always visible using mammography). If the marker or hematoma is not sufficiently visible using ultrasound, the hook-wire will be inserted using stereotactic guidance. A mammogram will be performed to assess position of the hookwire relative to the marker. If the wire position is not optimal then a further hookwire will be inserted using stereotactic guidance. For those participants who do not need to have surgery for their lesion their participation ends on the day of the stereotactic biopsy. Participants who need surgery will continue in the study until the specimen XRay and pathology results are available to allow determination of whether the lesion (marker) has been successfully removed. The time between stereotactic core biopsy and any surgery is usually 2-8 weeks depending on whether the lesion is malignant or not on the core biopsy histology.