Improved diagnosis of clinically occult breast lesions

Each year, an increasing number of Dutch women are diagnosed with
mammographically suspicious, nonpalpable breast lesions. The diagnostic work-up
of these breast lesions has evolved from surgical excision biopsy to image
guided, minimally invasive biopsy techniqueslarge core needle biopsy (LCNB)
over the past decades. However, the current minimally invasive biopsy
techniquesLCNB can not match the diagnostic accuracy of surgical excision
biopsy yet because of problems such as underestimation of disease severity and
unrepresentative sampling. As a result, LCNB is unable to provide a definitive
preoperative diagnosis in up to 25% of patients.
In order to reduce this high proportion of women in whom a definitive
preoperative diagnosis can not be established, radiofrequency-assisted intact
specimen biopsy (RFIB) was introduced. Where LCNB retrieves some 4-8 small
tissue fragments (2 x 20 mm), RFIB provides an intact (complete) biopsy
specimen of intermediate (10-15 x 20 mm) size. Previous studies have reported
substantial reductions in disease underestimation and unrepresentative
sampling. Thus, the use of RFIB may lead to higher proportions of patients with
definitive preoperative diagnosis as compared to LCNB.

To assess whether the use of RFIB instead of LCNB increases the probability of
a definitive preoperative histological diagnosis in women with suspicious
mammographic breast lesions. assess the *RFIB success rate*, defined as the
proportion of patients in which the histopathological diagnosis issued on the
RFIB specimen is equal to the final histopathological diagnosis. Secondary
objectives are to evaluate patient*s experiences regarding pain and cosmetic
outcome, adverse events and biopsy specimen quality.

Prospective cohort study.

The studied diagnostic intervention is a vacuum assisted percutaneous intact
biopsy of mammographically suspicious breast lesions under stereotactic
mammographic guidance. The intervention will be performed using the FDA and CE
approved IntactTM Breast Lesion Excision System.

RFIB will replace the standard biopsy procedure (LCNB) and thus does not burden
the patient as an extra investigational procedure. Burdens that are associated
with participation are a two-day delay in obtaining the biopsy result, because
of additional processing steps that are needed to enable pathological
assessment, and the time investment required for completing a questionnaire at
3 different time points. Additional risks associated with participation in the
study are hypothetical and consist of an increased chance of non-specific
biopsy related complications and burning of the skin.