GE Healthcare introduces it's new automated breast ultrasound for dense breast

There could not have been more appropriate time for the launch of GE Healthcare new Invenia Automated Breast Ultrasound (ABUS) 2.0 than October, which is celebrated as breast cancer awareness month. The Invenia ABUS is the only FDA approved 3D ultrasound system for supplemental screening for breast cancer along with mammography.

In conjunction with mammography, it increases the chances of cancer detection in the dense breast by 55%. All breasts are not the same, the density of breast is determined by a proportion of fat and breast tissue—when the percentage of breast tissue exceeds that of fat, breasts are labeled as being dense.

Dense breast tissue and cancer both appear white on mammograms, thereby creating a diagnostic dilemma for the radiologists. It is estimated that about 71% of all breast cancers occur in dense breast and 1 in 3 cancers are missed by mammography. 

In the USA, about 40% of women have dense breast; thereby putting them at increased risk of having breast cancer and detection at a late stage. Early detection of breast cancer increases the chance of cure and patients may void chemotherapy.

The Invenia ABUS uses particular software-based graphics processor to capture operator independent, high-quality images making it possible to reproduce consistent images every time the machine is used. Unlike manual device, the focal zone and grain are automatically adjusted eliminating the inter-operator variability.  All these features enable the Invenia to pick-up small cancers that are predominantly invasive but node negative,  culminating into substantial patient benefits.

Invenia ABUS also provides 2-mm thick coronal slices which allow the operator an efficient visualization of the entire breast for architectural distortions and multifocal disease. With the reconstruction of 2-mm thick coronal slices, it is easy to obtain a persistent orientation and location of the lesions relative to the nipple and to scan the entire breast from the skin to chest wall.

The machine is also designed keeping patients comfort at the forefront. The gentle Reverse Curve™ transducer is designed according to the natural contour of breast allowing full contact and effective compression. The operator can customize the examination by programmable scan protocols to personalize it to patient needs.

The windows 10 provides a user-friendly interface to review, interpret patients' results quickly. Compression time can be shortened once tissue acquisition is complete. The three-view layout and Auto Prior Compare enable the physician to compare the results and focus on a region of interest.

“We believe ABUS can help clinicians find significantly more cancers than mammography alone, especially in women with dense breasts,” said Luke Delaney, general manager of Automated Breast Ultrasound at GE Healthcare, in a published statement. “As breast ultrasound technology continues to advance, we are investing to continually improve image quality, workflow, and patient comfort – all of which contribute to early detection and improved outcomes.”

Here is a video about the Invenia ABUS 2.0 acquisition process

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Are you dense? What every woman and her healthcare provider needs to know.

courtesy: Are you dense

Nearly 20 plus years of research have provided sufficient evidence to link dense breast tissue and increased risk of missing cancer diagnosis by screening mammography. As the breast density increases, the reliability of mammogram as a screening tool for picking up breast malignancy decreases.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

Mammographic breast density is defined as the relative amount of radio-opaque (white) elements to radiolucent (black) fat on the image. Increase in the proportion of radio-opaque elements leads to greater mammographic breast density.

Radiologists find it difficult to distinguish between tumor and normal dense tissue, both of which appear white on a mammogram.

In fact, mammography will only detect 30% cancer in dense breasts and 80% in non-dense breasts.

Nearly 40% of women have dense breast, which means that only using mammography as a screening tool puts this population at high risk of missing the diagnosis, delayed diagnosis or diagnosis at very late stage of disease. A recent search of PubMed revealed nearly 3,027 studies on masking risk of dense breast tissue.

Increased density of breast is a casual as well as masking risk factor for breast cancer. According to the American Cancer Society, having heterogeneously or extremely dense breast tissue puts you at risk of breast cancer that is equivalent having one first-degree relative with breast cancer. (2.1 to 4 times the normal risk)

Also, women with dense breast are put at increased risk of developing contralateral breast cancer and interval cancer (cancer detected within 12 months of a normal mammogram)

A recent Breast Cancer Surveillance Consortium study noted that breast density exceeds all other risk factors like obesity, family history and delayed childbirth.

About 28 states in USA have passed law regarding the mandatory reporting of breast density and the necessary follow up thereafter, after women have a screening mammogram.

So, is there a standard protocol for supplemental screening if a woman is diagnosed of having dense breast on screening mammogram? No, unfortunately not, the medical community has not agreed on a protocol regarding supplemental screening for women with dense breasts.

In a position statement, the ACOG, identifies dense breast as a moderate risk factor but does not support routine use of adjunct screening modalities in an average risk woman with dense breast. The American Cancer Society urges the patients with dense breast to talk to healthcare providers about additional screening modalities and advises an MRI along with her yearly mammogram in a high-risk group.

The American College of Radiology identifies breast density as a controversial risk factor for breast cancer with no consensus that it confers sufficient risk to warrant supplemental screening.

At this time, it is highly suggested that patient should initiate a dialogue with her physician, regarding the protocol to be followed after the diagnosis of dense breast. Each patient should be individually evaluated about her risk of breast cancer based on her genetics, family history and other risk factors.

One suggested approach based on a paper presented by Lee C. at Society of Breast Imaging/American College of Radiology Breast Imaging Symposium; April 26, 2015; Orlando, FL is to use tomosynthesis for all levels of risk, supplemental whole-breast ultrasonography for women with average risk, and supplemental magnetic resonance imaging for women with intermediate and high risk

For women who are at high risk and also have a contraindication to magnetic resonance imaging, whole breast ultrasonography or molecular breast imaging, if available, may be an appropriate alternative.

courtesy: https://www.moffitt.org/media/6369/125.pdf

The current options available in addition to screening mammography are Tomosynthesis or 3D mammography, Ultrasound, Magnetic Resonance Imaging (MRI), Molecular Breast Imaging (MBI) or Breast Specific Gamma Imaging (BSGI) and Contrast Enhanced Spectral Mammography (CESM)

Nancy M. Cappello, Ph.D. has founded Are You Dense, Inc., and Are You Dense Advocacy, Inc., to educate women and general public about the challenges women with dense breast face regarding the screening tools for detecting early breast cancer.

Classification of Breast Density: American College of  Radiology. 

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