Feasibility of Using 3D Ultrasound in Breast Cancer Screening of Women with High Risk.

Handheld ultrasound plays an important role in the diagnosis of breast cancer
but is currently not used in screening, because scanning of the breast with the
available transducers is generally considered to be too time-consuming and too
limited by its viewing angles for whole breast evaluation.
Recently a new device became available that allows automated whole breast
scanning (3D Whole Breast Ultrasound [SomoVuTM]). With this technology
ultrasound may be transformed into an important modality for breast cancer
screening.
In particular in younger women with BRCA 1/2 mutation and dense breasts it may
outperform x-ray mammography, with the advantage of avoiding the use of
radiation. This is of great importance, as BRCA 1/2 carriers are more
susceptible to radiation induced breast carcinoma than non-carrier women.
Regular surveillance in women with high genetic or familial risk of breast
cancer is currently carried out in a protocol including MRI and mammography
(yearly) , and with clinical examination (every 6 months).

The main objective of this study is to determine the performance of whole
breast scanning with ultrasound (WBUS), combined with MRI, in a yearly breast
cancer screening program for high-risk women, compared to the current practice
of the combination of mammography and MRI.
Secondly, to assess the potential of WBUS in detecting -interval- tumors in the
6 month interval now present in the current screening program.
Further objectives are the development of guidelines to optimise image
acquisition and interpretation.

A prospective design will be used to investigate the detection accuracy of WBUS
in an ongoing yearly breast cancer screening program for high risk women
utilizing mammography and MRI.
A WBUS exam will be carried out every 6 months during a study period of two
years. Sensitivity and specificity will be compared to that of annual MRI and
mammography exams.

Use of ultrasound in breast imaging is not associated with any known hazards.
The extra burden for the participants will be kept to a minimum by scheduling
the exams at the time they visit the clinic for their regular screening exams
(every 6 months).
The exam itself is not discomforting and takes approximately 15 minutes.

The greatest benefit of the exam is expected at the visits where only physical
examination is currently conducted.
The current data suggest that the progression rate of breast neoplasia is
accelerated in women who carry BRCA1/2 deleterious mutations compared with
other patients who have breast carcinoma with or without a family history. This
increased progression rate should be taken into account when considering the
surveillance of asymptomatic women and a 6 months advancement in cancer
detection is therefore important [46, 47].
With WBUS cancers may be detected that would otherwise remain undetected until
the next screening exam utilizing MRI and mammography.

A negative side effect is an expected increase of needle biopsies.