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SonoCiné: Breast
Ultrasound Imaging for Early Breast Cancer Detection
FREQUENTLY ASKED QUESTIONS
What is SonoCiné?
What technology does SonoCiné use?
What is the difference between SonoCiné
and conventional ultrasound?
What is the difference between SonoCiné and mammography?
Will SonoCiné replace mammography?
What studies have been performed with SonoCiné?
What type of person is a candidate for SonoCiné?
What are the benefits and advantages of
SonoCiné?
Are there any side effects?
Is there anyone who shouldn't have a SonoCiné?
Where is SonoCiné available?
What should my patients expect during
the exam?
How should my patients prepare for
the exam?
What is the difference between screening
and diagnostic ultrasound?
What is the difference between
SonoCiné and regular ultrasound?
How much does a SonoCiné examination cost?
What type of payment is accepted?
When will I get exam results?
What is SonoCiné?
SonoCiné is a new
investigational
automated process designed to provide improved
ultrasound images for diagnosis. Series of images from different areas
of the body are transferred from an ultrasound machine to a PC computer
for optimum display. These images can be linked together to form a single
continuous loop or viewed as multiple individual loops. Each image is
the same digital bit map that is displayed on the original ultrasound
monitor, thus no information is lost because no data is compressed. The
loops are permanently stored on CD.
SonoCiné's first application has been for
investigational
breast cancer screening.
In current testing,
SonoCiné has been
able to detect some breast cancers that
were missed by mammography and conventional ultrasound exams. A
computer-guided
mechanical
carrier
directs
the ultrasound transducer over the breasts in craniocaudad rows
(usually 4 cm wide). This
computerized-mechanization assures complete coverage of both breasts.
Because the transducer's position and travel speed is computer-controlled, the
exact location of any abnormality can be calculated within millimeters. A thin,
tight-fitting camisole is worn to hold the breasts in place. This camisole is
covered with gel for ultrasound transmission. It also provides some modesty during
the examination. A gel pad is placed over the nipple to reduce any obscuring
shadow. It also assists in locating the nipple sonographically as a reference
point.
Unlike screening mammography, which usually consists of 4 images, SonoCiné
captures and links together 2,000 to 5,000 breast ultrasound images during
each examination. When viewed rapidly, these images more easily demonstrate
distortions or disruptions of normal tissue pattern.
Permanently
recording all of
the images allows the radiologist to view the entire study, instead of
the single images chosen by the technologist doing the examination. In
the first
clinical study comparing SonoCiné and mammography, 20
cancers were found. SonoCiné detected 18 of these breast
cancers and mammography detected 15.
Since this first study, SonoCiné has discovered 7 additional cancers
missed by physical exam and/or mammography
SonoCiné also enhances the ability to recognize subtle differences
between cancer and normal tissue by increasing the contrast between the
cancer and background tissues. It does this by reducing the size of the
image without resolution loss. The resolution of the SonoCiné monitor
(2048 x 1536) is much greater than that of a traditional ultrasound monitor.
Thus, SonoCiné images can be read at a much smaller size with the
same detail. This smaller breast ultrasound image, when focused on, is
placed entirely on the cones of the retina so that there are no blind
spots during rapid viewing. Post-processing of the images
to control brightness and contrast also improves the ability to detect
cancer in its early stages.
What technology does SonoCiné use?
SonoCiné uses images produced by state-of-the-art ultrasound machines.
Although SonoCiné currently interfaces only with the latest
Siemens
Acuson
Sequoia™ and the Philips HDI 5000™, its technology is adaptable
to other platforms.
What is the difference between SonoCiné
and conventional ultrasound?
Although a positive tool, a regular ultrasound exam produces less than
30 permanent images of the breast. SonoCiné produces from 2,000
to 5,000
permanent
images so the chance of cancer detection is greater. To further
ensure that every centimeter of breast tissue is examined, the SonoCiné
scanner is
computer-guided over each breast in uniform, overlapping
rows that produce no gaps in between the resulting individual pictures.
The scanner's speed is also
computer-controlled so that even though
it moves up and down the breast, it is always moving at the same speed.
This also ensures a uniform set of images that starkly highlight any
break or change in tissue pattern-the sign of a possible cancer. Finally,
unlike with traditional ultrasound, the computer images produced during
a SonoCiné
exam can be adjusted for speed, size, brightness and contrast. As many as half of all potentially visible cancers, in women with dense breasts, may not be seen with conventional mammography.
What is the difference between SonoCiné
and mammography?
- SonoCiné uses ultrasound energy; mammography uses X-ray energy.
- Mammography "looks"' through the entire thickness of the
breast tissue. As a result, small cancers may be obscured by tissues
above or below the cancers. SonoCiné captures 2,000 to 5,000
4 x 4cm ultrasound images of breast tissue and links them into a cine
loop that visualizes both breasts completely. Each imaged area is seen
without the obscuring effects of adjacent tissue.
- Mammography uses different physical principles to identify cancer.
- Sometimes, cancers are easier to see by mammography than by ultrasound,
but at other times, ultrasound is more useful.
Therefore, in most women, the use of both screening mammography and
ultrasonography is better than either one alone.
Will SonoCiné replace mammography?
Mammography is able to see some tumors, particularly small areas of calcified
noninvasive cancer (DCIS), that are not visible by SonoCiné. Also,
mammography has a long history of cancer detection effectiveness. Hence,
SonoCiné should be performed in addition
to, not instead of screening mammography in high-risk women or
in women with dense breasts (most common among thin, younger women with
small breasts, especially Asian women, although
the only way to confirm dense breasts is with mammography).
What studies have been performed with SonoCiné?
The first clinical study of SonoCiné and mammography, completed
in early 2001, involved 496 women with high-risk factors, including
known mammographic or physical abnormalities. Twenty
cancers were found. SonoCiné detected 18 of these breast cancers
and mammography detected 15. Further substantiation of
the process is
currently being tested in an FDA-sanctioned,
multi-center clinical
trial.
What type of person is a candidate for SonoCiné?
SonoCiné breast ultrasound imaging is currently being used clinically
in Pasadena at the Hill
Breast Center. From SonoCiné's first clinical study and related
others (Radiology 2000; 217:832-840; Radiology 1998; 209:391; Radiology
2001; 218: 973-980; AJR 1999; 173: 921-929), it appears that SonoCiné
is of benefit to women with:
- One 1st degree or two 2nd degree relatives with a history or breast
cancer
- History of breast cancer or high-risk biopsy (LCIS or ADH)
- Mammographically moderately or very dense, glandular breast tissue
- Implants (all the tissue is visible superficial to the implants)
- Fibrocystic breasts
- Breast problems and who are pregnant
What are the benefits and advantages of SonoCiné?
Mammography saves tens of thousands of lives a year. However, a significant
percent of women, at least one-in-six, feel their cancer before it can be
seen on a screening mammogram. These women tend to have dense glandular tissue
that obscures the cancer mammographically. Ultrasound in general, and SonoCiné in particular has the advantage of looking at very
thin slices of breast tissue. This prevents the cancer from being obscured
by breast tissues next to it. Our data to date suggest that most of the
cancers greater than 5 mm in diameter and obscured by mammograms will
be seen by SonoCiné. However, mammography is able to see some tumors,
particularly small areas of calcified noninvasive cancer (DCIS), that
are not visible by SonoCiné. Also, mammography has a long history
of effective cancer detection. Therefore, SonoCiné should be performed in addition to, not instead of, screening
mammography in high-risk women or in women who have dense breasts.
Are there any side effects?
SonoCiné uses ultrasound energy, which is vibratory energy, unlike
mammography, which uses ionizing electromagnetic energy. Ultrasound energy
has been found safe enough at diagnostic levels for evaluation of the
fetus in pregnant women. Consequently there are no known side effects
from the examination.
However, like mammography, SonoCiné is not perfect in differentiating
cancer from non-cancerous tumors. Of the abnormalities diagnosed by mammography
and subsequently biopsied, between 65 and 90 percent are benign tissue
and the others (10 to 35 percent) are cancer. It is probable that of the
abnormalities diagnosed by SonoCiné and subsequently biopsied,
about half will be benign tissue and the other half cancers. Although
this ratio is better than mammography, a biopsy
of a non-cancerous lesion discovered by SonoCiné could be considered
a side effect.
Is there anyone who shouldn't have a SonoCiné?
SonoCiné is less effective in breasts that are either fatty or
large (greater than a double-D cup or a 44-inch chest. Using ultrasound,
cancers are more difficult to recognize in fatty tissue than in glandular
or dense breast tissue. Using mammography, the opposite is true. Also,
ultrasound is limited in its ability to penetrate large breasts. Consequently,
SonoCiné is not recommended for women with breasts larger than
a double-D cup, those who have a chest circumference
greater than 44 inches, or those whose breasts are mostly fatty tissue.
Where is SonoCiné available?
At present, SonoCiné breast ultrasound screening
is available only at the Hill Breast
Center in Pasadena, California.
What should my patients expect during the exam?
Before the examination your patient will be fitted with small gel pads
over the nipples and a camisole, which is then saturated with a liquid
gel that conducts vibrations from the ultrasound transducer. The camisole
is necessary to maintain the position of the breasts and the nipple pads
during the study. A sonographer guides the ultrasound transducer in a
mechanically-driven carrier over each breast in rows beginning from below
the clavicle to the inferior mammary fold. The pressure from the transducer
on the breast produces no discomfort. At
the end of the procedure the camisole and nipple pads are discarded and
the gel is removed with a damp cloth.
How should my patients prepare for the exam?
No particular preparation is necessary. However,
we suggest that you advise them to wear clothing that will allow them
to easily disrobe above the waist.
What is the difference between screening and
diagnostic ultrasound?
Diagnostic ultrasound, like diagnostic mammography, is employed to answer
a focal problem in the breast. This may be a physical or an imaging
finding. These problems are best investigated with conventional ultrasound
techniques directed specifically at the area or areas of clinical concern.
SonoCiné
is an
investigational
screening technique
that may be
useful in the discovery of occult or asymptomatic
breast cancers. In situations where a cancer is known to be present
by diagnostic means, SonoCiné
may be useful in searching for satellite or unsuspected multi-centric
disease.
What is the difference between SonoCiné
and conventional ultrasound?
Although a positive tool, a regular ultrasound usually consists of less
than 30 representative permanent images. The recognition of any abnormality
depends more on the skill of the sonographer (ultrasound technologist)
who performs the scan than on the physician who analyzes it. There is
no assurance that the breasts were examined in their entirety, that
the scanning was slow enough to produce enough images of small lesions
for recognition, or that any lesion that could have been recognized
was in fact recognized and photographed by the sonographer. On the other
hand, SonoCiné
uniformly captures 2,000 to 5,000
permanent
images, completely covering both breasts.
The speed and positioning of the
ultrasound
probe are computer-guided to
ensure optimum scanning. All the images are transferred
to a
CD as a permanent record
for later review by the
radiologist
using a high-resolution
monitor that enhances size, speed, brightness and
contrast.
How much does a SonoCiné examination
cost?
Generally, SonoCiné costs $300.
What type of payment is accepted?
Because SonoCiné is still a new,
investigational
breast cancer detection process,
it is not yet covered by any public or private insurance. Therefore,
each person having the exam will be responsible for the charge, which
may be paid by check or credit card. Some private insurance companies
may reimburse
the cost of a SonoCiné as breast ultrasound screening.
When will I get exam results?
The results will be mailed to you and your patient within two to three
working days of the examination.
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