Yes, we have conducted two clinical trials: in April and May 2014 we studied 51 healthy volunteers plus seven patients with biopsy-proven breast cancer, while in November and December 2015 we studied a further 50 volunteers and ten patients. The trials took place at the University of Cape Town and Groote Schuur Hospital respectively. Each subject had full-field digital mammograms and 3D automated breast ultrasound images taken of both breasts. Click here for a story describing the paper published in Clinical Imaging based on the first clinical trial, and click here for a story about the second trial that was published in Diagnostics where our Aceso system featured on the cover page.
Yes, that is the whole purpose of Aceso: the ultrasound can identify lesions in dense breast tissue when that same lesion is occult (i.e. not seen) in the mammogram. Click here for an example. Since dense breast tissue is found in 40% of women of screening age, it is important to be able to detect lesions at the initial examination.
No other company currently has a system like Aceso that combines both FFDM and ABUS in one device, although there has been research conducted at the University of Heidelberg in Germany whose researchers collaborated with Siemens, and at the University of Michigan whose engineers developed a prototype with the assistance of GE Healthcare. Click here for a link to a story about these two prototype systems.
CapeRay secured ISO 13485 certification, as well as the CE Mark for our Pandia digital X-ray camera in June 2012. The ISO certification has been renewed each year since then, while in November 2017 CapeRay secured the CE Mark for Aceso, our dual-modality system that combines full-field digital mammography (FFDM) and automated breast ultrasound (ABUS) in a single product. We are currently in the process of renewing both our ISO 13485 certification and CE Mark and anticipate having these in place in Q2 of 2020. We initiated the process for securing FDA clearance for Aceso during the second half of 2019 and will be submitting our full application in 2020.
We anticipate that Aceso will be commercially available in the European Union, the Middle East and South Africa in Q2 of 2020.
There are two major advantages of gathering the images simultaneously. First, there is a considerable savings in time: just 10 minutes versus 30 minutes when gathering the images with separate X-ray and ultrasound systems. Second, there is the ease of co-registration, with the breast in the same degree of compression and orientation when Aceso acquires the images.
A screening examination is conducted on a population that is considered to be healthy, whereas a diagnostic examination is conducted on a person when there’s a high suspicion of pathology. Click here for a story about screening as defined by the World Health Organization.
Once you have filled out the necessary paperwork, a mammogram should take no more than 10 minutes. This includes two views (cranio-caudal or top-to-bottom, and medio-lateral oblique or from the side) of the left and right breasts. If you also have an ultrasound examination, that will take another 20 minutes. One of the major advantages of CapeRay’s Aceso system is that it takes just 10 minutes to acquire both X-ray and 3D ultrasound images.
Yes, there is a very small risk from ionizing radiation when a mammogram (i.e. an X-ray) is taken of the breast. However, the dose level is much lower than other procedures such as a computerized tomography (CT) scan. Since the lifetime risk of breast cancer is estimated at one in eight, the benefits of early detection by mammography far outweigh the radiation. Click here for a story about radiation risk and mammography.
Screening mammography is recommended for women aged between 40 and 70, and this should be done once every two years. If there is a history of breast or ovarian cancer in a woman’s family, then she should have a mammogram much earlier, preferably in her early 20s. This is a personal choice, however, as there are some drawbacks that all women should be aware of. Click here for a story that covers some of the controversy that surrounds screening mammography, especially the problem of overdiagnosis.
It takes about 30 seconds to acquire simultaneous X-ray and ultrasound images of the breast with Aceso, and during that period it is imperative that the breast be maintained in a stationary position. For this purpose, the breast is held with a light compression of between 30 and 50 Newtons, which is significantly less than other mammography systems. In a recent clinical trial, a majority of participants stated that they found Aceso to be far more comfortable than the other systems they had experienced.
At this stage it is difficult to say with any certainty but the answer is probably “yes” since the radiologist will have to read both the full-field digital mammograms as well as the 3D automated breast ultrasound images, and this takes time. The increase in cost has to be weighed up against the increased likelihood that the radiologist will make the correct diagnosis. The idea is to minimize both the false negatives, which can have devastating consequences, and the false positives, which can lead to anxiety and an unnecessary procedure like a biopsy.
There are three reasons why MRI will be unlikely to replace mammography as a screening method any time soon. First, there is the cost, with MRI costing up to ten times as much as a full-field digital mammography system. Second, is time: it can take 30 minutes and more to acquire MRI images compared with 10 minutes for mammography. Finally, MRI requires a contrast agent to be injected into the woman’s blood stream and that carries both danger and discomfort. Click here for a report on MRI as a screening tool for breast cancer.
Recent research has confirmed that smoking is a contributing risk factor for developing breast cancer. So too is second hand smoke. Click here for a story about the regulation of e-cigarettes.
Regarding alcohol consumption, more than one drink per day has been shown to increase the risk of breast cancer significantly. Alcohol intake increases the oestrogen levels in a woman’s bloodstream and this can contribute to the risk.
According to the National Breast Cancer Foundation in the USA, a nutritious low-fat diet with fruits and green and orange vegetables can reduce the risk of breast cancer, whereas a high-fat diet will increase the risk because it triggers the production of oestrogen. Click here for a story about lifestyle choices that can reduce the risk of developing breast cancer.
Since exercise boosts the immune system and helps to control body weight, a woman can lower her risk of breast cancer by exercising three times a week for 30 to 60 minutes at a time. Click here for an article about the benefits of exercise.
There is a small but significant breast cancer risk for women who have been using birth control pills for more than five years. Oral contraception is not normally recommended for young women who have a significant family history of breast cancer.
There is a known breast cancer risk for hormone replacement therapy (HRT), especially for women who have other known risk factors. They should instead seek safer alternatives.
A breast self-examination (BSE) should be done once a month, 7 to 10 days after the menstrual cycle for women who are still menstruating. All women should speak to their doctor about the appropriate method to use for a BSE and what signs to look for. It’s important to note that the majority of lumps are benign, although a woman should speak to her doctor immediately if she discovers a palpable lump.
We do not have any jobs currently available at CapeRay but that situation might well change in the future. When we are looking to hire a new person we place an advertisement on our home page and so we encourage you to visit our website on a regular basis.
Yes, we have accommodated both interns and job shadow students in the past. It all depends on what we are doing at the time. So, if you are interested, we encourage you to fill out a form on our website and tell us about yourself. Click here for a link to the relevant page.