"Breast
Companion® is a computer-aided system (CADx)
intended for improving the ACR BI-RADS®
assessment of ultrasound images of lesions of the
female breast as part of the diagnostic workup"
Mammography is the pre-eminent
screening procedure for breast cancer that has very
high sensitivity but its lower specificity is well
documented. With medical and societal emphasis on
early detection of breast cancer, it appears the
emphasis to avoid missing a malignant lesion may
have led to a low positive biopsy rate for cancer,
between 10-31%. Apparently, in standard clinical
practice, if a lesion appears solid or
indeterminate, biopsy is recommended and breast
biopsy serves as the key diagnostic standard for
evaluation of breast masses for malignancy.
Unfortunately, breast biopsy is neither a
noninvasive nor an inexpensive procedure. Besides
affecting patients physically and emotionally, the
procedure frequently causes internal scarring which
may obscure the results of future mammograms. With
approximately 1,700,000 women undergoing breast
biopsy per year (Medical Review, 2006), combined
with a cost between $750-5000 per procedure, the
cost to the U.S. healthcare system is significant.
Ultrasound (US) is widely regarded as the adjunct
procedure of choice to mammography, especially for
distinguishing cystic from solid masses where
accuracy is 96-100%. However, earlier studies, in
which ultrasound was evaluated largely as a primary
screening tool, reported a wide variance in Positive
Predictive Value (PPV) and an unsettling range of
False Negative (FN) rate ranging from 0.3-30%. These
results led to many recommendations still extant
that breast ultrasound be used only to determine
cyst from solid and/or for needle guidance.
Furthermore, even with combined information from
mammography and ultrasound, each radiologist may
apply a different decision threshold to recommend
biopsy of a suspicious mass.
The American College of
Radiology (ACR) developed the Breast Imaging
Reporting and Data System (BI-RADS) program to guide
interpretation and reporting of breast ultrasound
exams. The ACR also manages a program to accredit
the clinical practice of breast ultrasound.
Similarly, in 1998 the American Institute of
Ultrasound in Medicine launched a program to
accredit the breast ultrasound practices of
radiologists and sonographers. These steps by
professional organizations are designed to improve
the quality and uniformity of care. Acceptance and
utilization of BI-RADS for ultrasound is increasing
but the research literature, including our own
reports, shows it is difficult to uniformly apply
the method and there is considerable variability of
lesion description and assessment between
radiologists. Currently, breast
biopsy serves as the key diagnostic tool in the
evaluation of breast masses for malignancy.
Unfortunately, breast biopsy is neither a benign
nor an inexpensive process. Besides affecting
patients physically and emotionally, the
procedure frequently causes internal scarring,
which obscures the results of future mammograms.
Until fairly recently, ultrasound in the U.S.
has been used only to distinguish cystic from
solid breast masses and to guide needle
biopsies. A number of positive studies in
Europe, Asia and the U.S. indicate that
high-quality ultrasound can provide radiologists
with a high degree of confidence in
differentiating many benign from malignant or
suspicious lesions detected by mammography.
Almen Laboratories has
developed and marketed sophisticated general
application image-processing software products for
imaging applications that provides extensive tools
to identify objects and image features of interest,
analyze the information content and then store,
retrieve and compare different objects in images of
interest based on this information. During the last
11 years, in collaboration with the University of
California, San Diego (UCSD) School of Medicine and
the Veterans Affairs Medical Center (VAMC) San
Diego, parts of this software system were tailored
to the needs of diagnostic breast ultrasound. The
resulting breast assessment assisting software was
created and validated under IRB-approved cohorts of
cases with available confirmation of the “truth” via
needle biopsy or 12-24 months follow-up for benign
lesions.
The accuracy
of decision making and interpretation of breast ultrasound can
be significantly improved by following implementation of a
structured method for breast lesion description and
interpretation through application of a computer-aided imaging
system based on BI-RADS lexicon guidelines. The system also
provides a computerized assessment of lesion (CLA) in question (also
in some publications referred as as Level of Suspicion (LOS) for cancer) using
these same guidelines. Our approach applies a database of
verified known findings (Reference Library) to which an unknown may be compared and
evaluated. Storage and retrieval of these images is accomplished
through identification of key information content of the breast
masses themselves (case-based reasoning). We suggest that
lesions of lower suspicion level such as intra-cystic masse
(complex cysts) and fibroadenoma may be ruled out as candidates for biopsy with
higher degree of confidence when image interpretation is made
with support of this computer-aided imaging system.
The completed, validated and
FDA approved product improves accuracy
of practitioners, potentially increasing
their confidence in breast ultrasound, reduce
variability of interpretations, and increase
ultrasound’s role in breast cancer detection and
management. The software automatically produces
the radiologist created BI-RADS Report. More
technical details can be found at the dedicated to
these software systems web site at
www.breastcompanion.com
Validation results suggest that
more accurate application of BI-RADS assessment
for diagnostic ultrasound could in future help reduce the number of biopsies by 40% with a
cost savings of well over $1 billion per year in
the USA, mainly by reducing the number of False
Positives.
This site is developed
for the purpose of educating professionals and
individuals in the developed Breast Ultrasound
CADx technology and make such technology widely
available for computer-aided BI-RADS Assessment
and Lexicon implementation
based on established and FDA approved reporting
system (BI-RADS).
