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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GE press release

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New 3-D printed, air-powered, biopsy robot that can collect sample inside MRI unveiled

The University of Twente revealed its latest version of world’s most accurate 3D-printed biopsy robot during the Surgical Robot Challenge at the international Hamlyn Symposium in London. The robot is named Sunram 5 and is faster and accurate than its previous self.

Today, most breast biopsies are performed by handheld needles under sonographic guidance, based on previous radiological films. But, many a time the needle placement is not perfect because what was seen on MRI or mammography may look quite different on sonography. Coupled with human error, this may create serious problems such as a malignant lesion may be reported as benign.

MRI scanners are unparalleled in terms of locating lesions, and it would be perfect if a biopsy is taken under their guidance. This would though require a robot small enough to fit beside the patient under MRI robot that could fit. The robot should also be made of a material not influenced by strong magnetic field created by MRI.

Researchers at the Twente University, Netherlands, have tailor-made a robot to above specification. The robot is very small and easily fit under the breast compression device. It is powered by air pressure maintained through external pumps, which also enables it to be under operator control. It is made up of hard plastic except for the MR-conditional needle itself.

The dual speed motors in the updated model have improved the speed so as the robot can reach its target location in about 10 seconds. In case of any technical mishap, a safety mechanism in the device retracts the needle from the breast.

Here is the video showing how the new robot works.

University of Twente press release

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FDA issues warning against breast cancer screening by thermogram

The US-FDA has issued a consumer health alert that thermogram breast cancer screening test is no substitute for mammography because of lack of scientific evidence in favor of thermogram.

This alert was issued in wake of reports received from many healthcare centers and patients that many providers are misleading patients into believing that thermogram can be a substitute for mammography.

Helen J. Barr, M.D., director of the Division of Mammography Quality Standards in the FDA’s Center for Devices and Radiological Health said, “Plenty of evidence shows that mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages. You should not rely solely on thermography for the screening or diagnosis of breast cancer.”

Those patients who are screened with thermogram may be falsely assured that they do not have cancer as it has high false negative results. Similarly, patients may receive a false diagnosis of breast cancer when in fact they do not have any lesion.

Thermography was only cleared by FDA as an adjunct tool, to be used with a primary screening method. Some women prefer to get the test done as it is painless and does not expose the patient to radiation.  

FDA also stressed that claims by websites that thermography detects cancers earlier than other screening methods does not have any scientific evidence.

FDA has further taken regulatory action against manufacturers of thermography devices and healthcare providers who are misleading patients to believe that thermography can replace mammography.

FDA has put the alert on consumer update page and it continues to monitor the situation.

FDA consumer alert 

Media Courtesy: FDA

ACOG updates its mammography screening guidelines; stressing emphasis on shared decision making.

courtesy: CBS news

ACOG today released a committee opinion updating its guidelines on Breast Cancer Risk Assessment and Screening in Average-Risk Women. This replaces the Practice Bulletin Number 122, August 2011.

This recent update lays emphasis on joint decision making, involving the patient and her physician.

Women who are average risk for breast cancer should be offered her first screening mammogram at age 40. No additional benefits are gained by starting screening before age 40. If women have not begun screening in 40s, they should begin screening mammography by no later than age 50 years.

The physician should have detail conversation with the patients about potential benefits and harm. For women who begin screening in early 40s, the benefits derived are smaller as compared to women who are older. But, the women can make an informed decision and opt for regular screening or wait till they reach 50s.

Average risk women should undergo screening mammography every 1 or 2 years, based on shared decision. “Biennial screening mammography, particularly after age 55 years, is a reasonable option to reduce the frequency of harms, as long as patient counseling includes a discussion that with decreased screening comes some reduction in benefits,” says the bulletin. 

The screening should continue till 75 years of age. Screening past 75 years depends on individual patient characteristics like her general health and expected life span.

The U.S.Preventive Services Task Force recommends that women should start regular mammograms at 50, and that women in their 40s should make an individual decision about whether or not to screen. The American Cancer Society says screening should be offered starting at age 40, and outright recommends starting at 45. And the National Comprehensive Cancer Network, an alliance of major cancer centers, recommends starting at 40.                                    

Recommendations from various organizations compared. Adapted from ACOG Bulletin.

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The different recommendations stem from a desire of all these groups to balance the benefits and harms of mammography and the way these societies interpret the data.

Christopher Zahn, vice president of practice activities at ACOG says,” "All three [schedules] are reasonable approaches to take, a patient's preferences and values need to be an important part."

Harms of screening mammography are anxiety and distress, false positive results, unnecessary biopsy and surgeries and radiation exposure.

Based on limited or inconsistent scientific evidence, Breast Self-Examinations (BSE) are not recommended because there is a risk of harm from false-positive test results and a lack of evidence of benefit. Screening clinical breast examination may be offered to these average risk women after a detailed discussion about uncertainty of additional benefits and the possibility of adverse consequences of clinical breast examination. The frequency of screening clinical breast examination is every 1–3 years for women aged 25–39 years and annually for women aged 40 years and older are reasonable.

Screening clinical breast examination is an important part of evaluation of high risk women and women with symptoms.

It should be noted that all these recommendations apply to average risk women. Women who are high risk should follow different set of guidelines as advised by their physicians. The high-risk factors for developing breast cancer according to the bulletin are female sex and advancing age, family history, BRCA mutation, dense breast, nulliparity, older age at first birth, older age at menopause, younger age at menarche and receiving therapeutic ionizing radiations.

The full text of  committee opinion can be accessed here.

Innovative Breast Ultrasound system for cancer screening in women with dense breast.

Courtesy: GE systems

Mammography is the gold standard for early detection and cancer screening for breast cancer, however it may miss the cancer in about one third of patients with dense breast tissue. According to a study about 40% of women in US have dense breast.

Dense breast also increases the likelihood of developing cancer by 5 to 6 times as compared to women with normal breast density.  Often the cancers are detected very late in women with dense tissue because of imaging difficulty.

GE Introduced a new version of its automated breast ultrasound system ‘the Invenia Automated Breast Ultrasound System(ABUS)’.

Courtesy: GE systems

GE says, “Invenia ABUS is a comfortable, non-ionizing alternative to other supplemental screening options for women with dense breast tissue. When used in addition to mammography, Invenia ABUS can improve breast cancer detection by 35.7 percent over mammography alone.” It is not a substitute for mammography but a non-ionizing adjunct to the procedure and can detect early stage, node negative, invasive cancers.

The Invenia ABUS system is designed for screening and it shifts the diagnostic approach from hardware based system to software based system. The system creates a reproducible, fully automated scan that takes 15 minutes to complete. It captures whole breast three dimensional images that are displayed at the workstation as 2mm coronal view slices.

It also adjusts the signals levels in the nipple area so that it looks like surrounding tissue enhancing visualization. Other distinct features helping in better image quality and increasing visualization are Breast Border Detection and Chest Wall Detection.

The reverse curve transducer is designed to enhance the breast coverage and patient’s comfort during examination. Patients also report to be more comfortable because of absence of the pressing and pain sensation so common to mammography.

The system received FDA approval in 2014 and currently 180 hospitals are using it. 

The European Asymptomatic Screening Study screened 1,668 women between the ages of 40-74 with ABUS in a 15-minute exam after they had already undergone digital mammography screening. The results showed a 57 percent relative increase in cancer detection.

The findings were equivalent to 6.6 cancers detected per 1,000 women, compared with 4.2 percent of those who received mammography alone.

In a recent interview with medgadget[1] at the National Consortium of Breast Centers Conference,[2]Dr. Georgia Giakoumis Spear of NorthShore University Health System affirmed that ABUS is complementary to mammography and it is not meant for replacing it.  The NorthShore hospital is using the system for 15 months and is extremely satisfied with the results. They found about 25 cases of occult breast cancer not detected by mammography. 

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[1] http://www.medgadget.com/2017/03/breast-cancer-detection-using-ultrasound-interview-dr-georgia-giakoumis-spear-northshore-university-health-system.html

[2] https://www2.breastcare.org/welcome-to-the-annual-national-interdisciplinary-breast-center-conference/