Wednesday, July 7, 2021

Ultrasound Significantly Reduces False Readings of DENSE BREASTS




TRIBUTE TO A GLOBAL CRUSADER
(Play Video-L) The NY Cancer Resource Alliance gives loving tribute to Dr. Nancy Cappello, co-founder of "Are You Dense" and chief crusader of the mission to bring change to the protocols and standards of Early Detection.   Her organization embarked in a global advocacy project to win legislation for dense breast scanning and to bring awareness to the need for better technologies and imaging interpretation. Today, her loving husband Joe continues her unending fight to save more lives through awareness, advocacy and her crusade for change.  (Also see below to read her full story in our ORG SPOTLIGHT section)


7/8/2021- A wave of recognized medical sites, journals and reports  are now indicating that dense breast tissue increases the risk of developing breast cancer and often masks a tumor from being seen on the mammogram since dense tissue is white and cancerous tissue is also white. Mammograms are the standard screening test for breast cancer, however, in the 21st Century, ultrasound non invasive imaging is the preferred exam for dense “lumpy” mammary disease.   

The 1st World Conference of Breast Ultrasound in Philadelphia (1979) recognized ultrasound superiority in dense breast diagnostics but the density level was never quantified until recently. Mammography assessment of breast density is graded into four categories. Mammographers readily admit that these levels are subjective at best and technical factors such as mammary tissue compression and x-ray voltage/amperage dramatically influence the darkness or whiteness of the image.

What Does It Mean to Have Dense Breasts?


A mammogram shows how dense your breasts are. When you get the results of your mammogram, you may also be told if your breasts have low or high density. Women with dense breasts have a higher risk of getting breast cancer.


















PARTS OF THE BREAST
A woman’s breast has three kinds of tissue: FIBROUS TISSUE holds the breast tissue in place.  GLANDULAR TISSUE is the part of the breast that makes milk, called the lobes, and the tubes that carry milk to the nipple, called ducts. Together, fibrous and glandular tissue are called fibroglandular tissue.  FATTY TISSUE fills the space between the fibrous tissue, lobes, and ducts. It gives the breasts their size and shape.

BREAST CANCER RISK: Women with dense breasts have a higher chance of getting breast cancer. The more dense your breasts are, the higher your risk. Scientists don’t know for sure why this is true. Breast cancer patients who have dense breasts are not more likely to die from breast cancer than patients with non-dense (fatty) breasts.



URGENCY IN THE EVOLUTION OF TECHNOLOGY & IMAGING STRATEGIES FOR DENSE BREASTS

Written by: Dr. Robert L. Bard

Decades since the advent of breast scanning technology, innovations in non-invasive diagnostic imaging provide new options in the field of early detection. These technologies directly align with breast density screening (and are part of the Bard Breast Density Diagnostic Program) include:

• Doppler blood flow
• Contrast enhanced ultrasound vascularity 
• 3D Vessel Density Histogram 
• 4D Volumetric Density Histogram
• Strain and shear wave tissue Elastography 
• 3 T MRI 
• Optical Computed Tomography (OCT) for nipple lesions
• Reflectance Confocal Microscopy (RCM)  for dermal invasion
• Hybrid Mammo Imaging Fusion
 Thermo-sensor
 Trans Illumination
 Near Infrared Specroscopy

Hybrid imaging refers to combining diagnostic modalities to assess disease and monitor therapy. A useful combination of options is the tumor vessel flow density to assess aggression and treatment progress. Similarly, tissue elastography is useful for border detection of malignant masses.








4D VOLUMETRIC DENSITY HISTOGRAM
This new variation of the 4D ultrasound imaging involves real time scanning of the entire breast and focusing of the greatest density tissue with 3D volumetric capture of the tissue. The computer searches the gray level of the images under study and provides a percentage (%) number of the whiteness of the volume under study.

This investigative process began in 2017 under a study of scar tissue and presented at the 2018 ASLMS meeting using elastography and volumetric sonogram density analysis. Breast cancers, like scar tissue, are dark while fibrocystic abnormal tissues is more white.

The clinical utility of 4D image acquisition is:

1. Automated electronics sampling of the tissue volume in real time

2. 200-300 images of a data set are generated in 5-15 seconds

3. The process is User-INDEPENDENT unlike standard 2D ultrasound which is highly user dependent

4. The data set for serial studies uses fixed parameters so that treatment efficacy may be rapidly compared 



INNOVATIONS REFLECTING A NEW IMAGING STRATEGY: MEET THE ABUS
The medical imaging and cancer communities are now taking strides toward the dedicated scanning of Dense Breasts.  As mammograms have been known to have difficulty seeing tumors through dense breast tissue, the demand to upgrade imaging standards is at its highest. Dense breasted patients carry the risk of a mis-read which may miss advanced cases of breast cancer.  

According to GE Healthcare, "Approximately 40% of women have dense breasts, one of the strongest common risk factors for developing breast cancer.  Having dense breasts increases a woman's chance of developing breast cancer by four to six times, and seventy-one percent of breast cancers are found in dense breasts.

Clinical evidence is growing about the effectiveness of ultrasound for finding small, node-negative, invasive cancers missed by mammography. In 2018, GE Healthcare launched the Invenia automated breast ultrasound (ABUS) 2.0 system in the U.S. This FDA Approveed ultrasound supplemental breast screening technology specifically designed for detecting cancer in dense breast tissue. When used in addition to mammography, Invenia ABUS can improve breast cancer detection by 55 percent over mammography alone. Invenia ABUS 2.0 supplemental imaging is designed for the screening environment, specifically for dense breast imaging. Invenia ABUS 2.0 diminishes operator variability and creates 3D ultrasound volumes to enable comprehensive analysis and comparison to multimodality exams. [1]

“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. “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.” [1]


Dense Breasts: Answers to Commonly Asked Questions 

Q: How common are Dense Breasts?
A: Nearly half of all women age 40 and older who get mammograms are found to have dense breasts. Breast density is often inherited, but other factors can influence it. Factors associated with lower breast density include increasing age, having children, and using tamoxifen. Factors associated with higher breast density include using postmenopausal hormone replacement therapy and having a low body mass index.

Q: Are dense breasts a risk factor for breast cancer?
A: Yes, women with dense breasts have a higher risk of breast cancer than women with fatty breasts, and the risk increases with increasing breast density. This increased risk is separate from the effect (false negatives) of dense breasts on the ability to read a mammogram.



ORG SPOTLIGHT:

“ARE YOU DENSE”- FORGING A SMART, NEW PROTOCOL IN BREAST CANCER SCREENING

By: Joe Cappello of “Are You Dense” (areyoudense.org & areyoudenseadvocacy.org) | Edited by: Carmen R. DeWitt

Dr. Nancy Cappello's Story: "I have dense breast tissue – and women like me (2/3 of pre-menopausal and 1/4 of post menopausal) have less than a 48% chance of having breast cancer detected by a mammogram. In November 2003 I had my yearly mammogram and my "Happy Gram" report that I received stated that my mammogram was "NORMAL" and that there were "no significant findings." Six weeks later at my annual exam in January, my doctor felt a ridge in my right breast and sent me for another mammogram and an ultrasound. The mammogram revealed "nothing" yet the ultrasound detected a large 2.5 cm suspicious lesion, which was later confirmed to be stage 3c breast cancer, as the cancer had metastasized to 13 lymph nodes.... Since then, I learned that there are many women like me with recent normal mammogram reports with a hidden intruder stealing their life.  I am on a quest to expose this best-kept secret of dense breast tissue to ensure that women with dense breast tissue receive screening and diagnostic measures to find cancer at its earliest stage - isn't that the purpose of Screening Programs?"

Nancy's story is a widely common one, and demands to be recognized to change the current standards.  We established an advocacy group to help create a new standard protocol for diagnosis because the current standard is clearly an injustice to ALL women. This includes public education and awareness for the many women who get side swiped because of a lack of understanding and clinical information. 

Our advocacy work led us to reach out to our legislators, explore the current insurance coverages and eventually got our first win with a disclosure law in 2009, making Connecticut the first state in the nation to pass legislation making it a law for Docs to disclose to the patient if they have dense breast tissue.   This says that if a woman has dense breasts, she'd must be told by her physician that she's got dense breast there's alternative screening. This includes options like an ultrasound or an MRI.  Also, two years ago, ‘Are You Dense Advocacy, Inc.’ was instrumental in passing the first national dense breast disclosure law. We are now working with Sen. Feinstein to enact this legislation.  

FORGING A NATIONAL MOVEMENT
 
It used to be that when you Googled ‘dense breast’, there was next to NO information available. But over time, as we started making ‘noise’ about this issue, more and more interest began coming our way.  As news broke of our ‘touchdown’ with our state, it wasn’t long before other states started asking how we did it. Before long, Nancy started helping women across the country and the next state was Texas. She helped the girl down in Texas to get legislation passed – and next came our public educational website for the many others who definitely need this.

Nancy quit her job with the state of Connecticut and started doing “Are You Dense” full-time and she helped pass 38 different laws in 38 states.  It's a tremendous amount of work to pass laws on a state by state basis, but she was really the catalyst. Nancy was the person behind and the voice and the face behind dense breast tissue. As outreach work goes, we created a major effort around what we've done now.  Manufacturers are supporting our interest as far as the expansion of full breast automated ultrasound and others came into existence (and are doing quite well) because of our efforts.

* For more information about Nancy and Joe Cappello's national mission, visit: areyoudense.org and areyoudenseadvocacy.org


From the Surgical Side...
"THEY MADE A LAW REQUIRING DENSE BREAST SCANNING"

In New Jersey, we have the Breast Density Law that literally says women with very dense breasts should be getting more than just screening mammography and the insurance companies have to cover. And that can either be an ultrasound or an MRI, but women over 40 do not usually like the idea of getting an MRI and gadolinium IV each year. Instead, adding ultrasound allows you to scan the whole breast and see through the very dense breast tissue. Ultrasounds will also work to the full depth of the breath straight down to the chest wall, so that if there are any masses,  it will see right through the fibers and thick tissue- not limited like mammogram. 

Even extremely dense breast patients should get a mammogram because it also shows things like calcifications-- something that the average ultrasound tech may find harder to capture. Women with extremely dense breast definitely can benefit from added surveillance because as your breasts get more dense, mammography can miss things.  Due to a higher volume of dense tissue, a little tumor can hide underneath fibercystic tissue making it very hard to see in mammography, even with tomosynthesis or the 3d mammo. 

By: Dr. Stephen Chagares | https://www.drchagares.com


TREATMENT OPTIONS
Risk stratification is important since the cost/benefit of any therapy must be weighed against the likelihood of health consequences. Hormone treatments have been controversial for 50 years and remains so to date. Since Dr. Selig Strax (my late partner) developed the “lumpectomy” for conservative therapy of breast cancer at Mt Sinai Medical Center in the 1960’s, advances in limiting tissue damage have yielded progress in chemotherapy, radiation therapy and immunotherapy. Similarly focal treatment options that began with prostate cancer in 2000 with HIFU (High Intensity Focused Ultrasound) are now found in thyroid and breast treatment centers and Laser Ablation and Cryo Ablation are now available alternatives. 

Elastography is used worldwide since 2010 for cancer detection because cancer is hard (inelastic) and benign tissue is soft (elastic).  This quantitative technology for cancer detection has not been adapted for breast density analysis to date.


REFERENCES

1) GE.com/ Setting A New Standard for Breast Care: GE Healthcare Introduces Invenia ABUS 2.0  https://www.ge.com/news/press-releases/setting-new-standard-breast-care-ge-healthcare-introduces-invenia-abus-20#_ftn1

1) Breast density and risk- European Radiology 31:4839-4847, 2021

2) 4D histogram analysis of malignancy-  Mt Sinai Surgical Symposium  2020- 3D/4D breast density histogram
3) Proceedings: Male Breast Cancer Coalition 2019
4) Ultrasound imaging of subdermal pathology /Springer Heidelberg  2018
5) 3D Doppler imaging of malignant melanoma- Intl Dermatologic Surgery Symposium  2016
6) 3D Doppler imaging in dense breasts Proceedings:  2012 Societe Francaises de Radiologie



CONTRIBUTORS

DR. ROBERT L. BARD has paved the way for the diagnostic study of various cancers both clinically and academically. He runs an active NYC practice (Bard Diagnostic Imaging) using the latest in digital Imaging technology which has been also used to help guide biopsies and, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered Sonograms, Spectral Doppler, sonofluoroscopy, 3D/4D Image Reconstruction and the Spectral Doppler are safe, noninvasive, and does not use ionizing radiation. His commitment to lead the community of cancer imaging and diagnostic experts has led to the establishment of the "Get Checked Now!" campaign.

JOSEPH J. CAPPELLO married Nancy Marcucci, in 1974 and the story began.  Joe is the co-founder and executive director of Are You Dense, and Are You Dense Advocacy- in January of 2019 after Nancy’s passing from treatment related bone marrow cancer (MDS). His passion is to continue Nancy’s legacy by pursuing the goal that they set in 2004; that not one woman would die from a late stage breast cancer due to dense breast tissue. In 2009, Joe and Nancy championed the first in the nation breast density inform law in the State of Connecticut (and now, 36 States have breast density legislation).


Disclaimer & Copyright Notice: The materials provided on this website/web-based article are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

                                    


TUMOR DETECTION FOR DENSE BREASTS

BREAST CANCER DECODED  By:  Robert L. Bard, MD     CONCEPT AND APPROACH Drastic changes in the incidence, diagnosis and treatment of bre...